Positive pressure ventilation elbow and related masks, systems, and methods

ABSTRACT

A positive pressure ventilation (PPV) elbow connects to a PPV mask and a source of pressurized air from a ventilator. The elbow and includes an access valve that opens to provide access to the mouth of the patient without removing the mask and self-seals under pressure from the ventilator.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of PCT Application No.PCT/US2016/039117, filed on Jun. 23, 2016, which claims the benefit ofUS Provisional Patent Application Nos. 62/183,733, filed on Jun. 23,2015 and 62/252,577 filed on Nov. 8, 2015. This application is also acontinuation in part of PCT Application No. PCT/US2017/060480, filed onNov. 7, 2017, which claims the benefit of U.S. Provisional PatentApplications Nos. 62/418,787, filed on Nov. 7, 2016 and 62/568,314,filed on Oct. 4, 2017. All of the foregoing applications are herebyincorporated herein by reference in their entirety.

BACKGROUND 1. Field of the Invention

The present invention relates to devices and method for providing oralaccess with a non-invasive positive pressure mask.

2. Related Technology

Positive pressure ventilation (PPV) masks are currently used in themedical field for patients with poor oxygen saturation, sleep apnea, andother related respiratory problems. The mask includes a peripheralflexible membrane that contacts the face of the patient and creates aseal with the face using the positive pressure. An example of a positivepressure ventilation mask is disclosed in U.S. Pat. No. 6,513,526 toKwok. These types of masks, used with a ventilator, can provide positivepressure airflow for critically ill patients without the need tointubate the patient and/or allow earlier extubation.

Positive pressure masks require an effective seal around the facial areaand can be a hassle for clinicians or users to properly place. Once inplace, the positive pressure in the mask assists the patient's breathingby providing a proper amount of forced air necessary to maintainadequate inhalation and exhalation. In a matter of hours or days, themask can cause discomfort to the patient from dry mouth or nose, nasalcongestion, rhinitis or runny nose, facial irritations, bloody noses,dry mucosal tissue, dry lips, increased risk of respiratory infection,or other difficulties managing oral or nasal airway.

Positive pressure masks are also used to treat sleep apnea. While thesepatients are typically not critically ill, they suffer from theinconvenience of dryness of the airway and the inability to access theiroral airway without taking the mask off.

SUMMARY

The present invention relates to appliance modules, capnometry modules,nebulizer modules, oral care kits, ventilators and ventilator systemsand methods of performing PPV procedures using the modules and systems.The devices and methods utilize an access port through the mask (eitherthe mask shell or an elbow connected to the shell). The access portprovides access to the oral or nasal cavity from outside the ventilatorcircuit without removing the mask.

Some embodiments of the invention relate to devices and methods that canbe placed through the access port of the positive pressure ventilationmask. The devices include a PPV appliance adapter that has a first sealsurface and a second seal surface to seal the appliance module to theaccess port and to seal the adapter to the appliance. The second sealsurface defines an aperture that forms the second PPV seal with theappliance. The appliance adapter has two surfaces, one on the inside ofthe mask, which is exposed to the ventilator pressure and a second thatis outside the mask and exposed to pressures external to the PPV maskwhen the adapter is attached.

In some embodiments, the appliance module includes an elongate tubepositioned in the aperture of the adapter and a working head positionedon the elongate tube. The elongate tube and the aperture slide relativeto one another while maintaining the second seal. The working head has alarger diameter than the aperture, which prevents the working head frombeing passed through the aperture. The working head is positioned oninside of the adapter such that the working head can be used in the oralor nasal cavity of the patient when the appliance module is insertedinto the access port.

Examples of appliances that may be included in the appliance moduleaccording to the invention include, but are not limited to, a suctionswab, a suction brush, a yankauer, a cannula, a swab applicator, acapnometry sampling device, a nebulizer device, and the like.

Some embodiments of the invention relate to PPV masks that have a valvepositioned in the access port that seals under pressure from theventilator. An adapter (e.g., an appliance adapter) is configured toseal with the access port and open the valve. When the adapter isremoved from the access port, the valve seals under the positivepressure of the ventilator. The access port and self-sealing valve maybe positioned in a shell of the PPV mask or in an elbow connector of themask. The valve can have curvature and/or leaflets that are pushedtogether from pressure on the inside of the mask to seal the valve whenthe valve is not being used (i.e., free of an appliance). The valve canalso be self-reverting. The valve can be made of an elastomeric materialand mounted to the mask such that its movable members will revert backto a self-sealing position when inverted. The valves can be relativelylarge to allow for oral care appliances to be passed therethrough. Insome embodiments, the valve opens to a diameter of at least 5, 10, 15,or 20 mm.

Another embodiment of the invention relates to a suction brush module.The suction brush module has a working head that includes a suctionbrush. The brush adapter of the module includes a receptacle configuredto house the brush and an aperture centrally located at a proximal endof the receptacle. The suction brush includes a suction head with anelongate tubing connected to the head. The elongate tubing is centrallylocated on a proximal end of the such that the aperture of the adapterand the suction brush tubing align axially. In some embodiments, thelongitudinal axis of the tubing connector is off center from thelongitudinal axis of the brush head by less than 30%, 20%, 10%, or 5%.

Another embodiment relates to a covered yankauer. The yankauer has ayankauer adapter that seals with an access port of an PPV mask. Theyankauer adapter also includes a receptacle for housing the yankauer ina covered position. The yankauer is movable between a covered positionand an exposed position in which the yankauer is extended from thecover. The yankauer has a cover that attaches to the adapter and theyankauer tubing and is compressed when the yankauer is moved from thecovered position to the extended position.

Another embodiment relates to an oral care kit that includesindividually packaged appliances. Each package includes an appliancemodule. In some embodiments, the individual packages include a tray withat least two compartments, one of which houses an appliance module andthe other an oral rinse solution. The tray is sealed with a packagingmaterial around the first and second compartments and can be opened bypealing.

Another embodiment relates to a capnometry module that includes anadapter configured to attach to an access port of the PPV mask. Thecapnometry module includes a support housing that extends on the insideof the adapter into the mouth of a person wearing the PPV mask with themodule attached. The support housing includes a sampling line with aninlet at the oral end of the support housing. The sampling line passesthrough the adapter to the outside portion of the adapter where itconnects to a capnometry device capable of measuring CO₂ in the sampledair.

In another embodiment, the capnometry adapter has a support housing thatmoves between a covered position and an extended position for use. Thesupport housing forms a second slidable seal with the adapter such thatthe PPV seal is maintained as the support housing is inserted into themouth of a person wearing the PPV mask. The moveable support housing mayalso include a sheath for covering the support housing when it is in thecovered position (i.e., the oral end is retracted into the receptacle).

Another embodiment relates to a nebulizer module with an adapterconfigured to form a seal with a PPV mask. The adapter includes a tubingon the inside that extends into an elbow or a shell of a mask. An oralend of the tubing delivers nebulized gas into the mask or mouth of apatient. The opposite end of the tubing abuts a vibrating element. Theopposite side of the vibrating element is in contact with a fluidreservoir that holds the fluid to be nebulized. The nebulizer module caninclude a control module for driving the vibrating element, a powersupply, and a user input device (e.g., a button) housed within theadapter. Or alternatively the module can be connected to a control unitvia wire.

Another embodiment of the invention relates to a ventilator system thathas a control module that receives pressure input from a ventilationcircuit and detects a suction pressure signal indicative of changes inpressure caused by operation of a suction appliance in the PPV mask. Thecontrol module uses the detected suction pressure signal when generatingan output signal for driving the pressure generating system thatproduces positive pressure for the ventilator circuit (e.g., the suctionpressure signal is filtered out).

Another embodiment of the invention relates to a ventilator thatdisplays a menu to a user for selecting an oral care setting. Uponreceiving input (selecting the oral care setting) the ventilator adjustsat least one parameter of the ventilator (e.g., temporarily sets atarget leak rate higher for trigger an alarm).

DESCRIPTION OF DRAWINGS

FIG. 1A illustrates a full face positive pressure mask, including anelbow having a valve that seals under ventilator pressure;

FIG. 1B illustrates a ventilator system including a PPV mask,ventilation circuit, and ventilator;

FIG. 2A is a perspective view of the elbow of FIG. 1A;

FIG. 2B is an exploded view of the elbow of FIG. 2A;

FIG. 2C is a cross section of the elbow of FIG. 2A;

FIG. 3A is top perspective view of the self-sealing valve of the elbowof FIG. 1;

FIG. 3B is a bottom perspective view of the valve of FIG. 3A;

FIG. 4A illustrates an alternative embodiment of a full face positivepressure mask, including an elbow a port having a cap and no value;

FIG. 4B illustrates an alternative embodiment of a full face positivepressure mask with an access port;

FIG. 5 illustrates an alternative embodiment of an elbow with a swivelconnector;

FIG. 6A illustrates a suction swab placed in an adapter in a coveredposition;

FIG. 6B shows the suction swab of FIG. 6A in a partially extendedposition;

FIG. 6C is a cross section of the suction swab as in FIG. 6A;

FIG. 7A-C illustrate the ring of the elbow of FIG. 3A and the adapter ofthe module of FIG. 6A in various positions relative to one another;

FIG. 8 illustrates an alternative embodiment of the adapter and ring ofFIG. 7B in which the adapter locks to the ring;

FIG. 9A is a cross section of the elbow of FIG. 1 and the suction swabmodule of FIG. 6A in a covered position;

FIG. 9B is a cross section of the elbow and module of FIG. 9A with thesuction swab partially extended into a shell of a mask;

FIG. 10 is an alternative embodiment of an adapter and appliance;

FIG. 11A shows a suction handle that includes a slider on/off switch;

FIG. 11B is a cross section of the suction handle of FIG. 11A in theclosed position;

FIG. 11C is a cross section of the suction handle of FIG. 11A in theopen position;

FIG. 12A illustrates a suction brush module;

FIG. 12B is a perspective view of the brush head of FIG. 12A;

FIG. 12C is a cross section of the brush head of FIG. 12A;

FIG. 13A illustrates a covered yankauer module;

FIG. 13B is a cross section of the adapter and working head of themodule of FIG. 13A;

FIG. 13C illustrates the module of FIG. 13A in the covered position;

FIG. 14 illustrates an alternative embodiment of a covered yankauermodule;

FIG. 15A illustrates a slidable capnometry module in an uncoveredposition;

FIG. 15B is a cross section of the module of FIG. 15A in a coveredposition;

FIG. 16A illustrates a cross-sectional partial view of an alternativeembodiment of a capnometry adapter and sampling line;

FIG. 16B illustrates a cross-sectional partial view of yet anotheralternative embodiment of a capnometry module having a fixed supporthousing;

FIG. 17A illustrates a perspective view of an endoscopy adapter;

FIG. 17B is a cross section of the endoscopy adapter of FIG. 17A.

FIG. 18 illustrates a sectional view of an alternative slit valve;

FIG. 19A is a perspective view of a nebulizer module with an adapterconfigured to form a seal with the mask of FIG. 1;

FIG. 19B is a cross section of the nebulizer of FIG. 19A;

FIG. 20A is a perspective view of a nebulizer module according to analternative embodiment of the invention;

FIG. 20B is a cross section of the nebulizer module of FIG. 20A; and

FIG. 21 is cross section of a nebulizer module according to yet anotherembodiment of the invention.

FIG. 22 is a block diagram of a positive pressure ventilator microphonesystem that includes the mask of FIG. 1A;

FIG. 23 is a cross section of a microphone module in an elbow connectorof FIG. 1A;

FIG. 24 is a component diagram of a portion of the microphone system ofFIG. 22;

FIG. 25A illustrates a microphone enclosure with microphone elements;

FIG. 25B illustrates an alternative embodiment of a microphone enclosurewith microphone elements;

FIG. 26 shows another embodiment of a microphone module; and

FIG. 27 shows a microphone housing with a removable foam end.

DETAILED DESCRIPTION

The present invention relates to positive pressure ventilation masks anddevices that provide or connect to and seal with a port of a positivepressure mask. The devices allow access to the mouth of the patientwhile maintaining sufficient positive pressure for the mask to sealand/or for the ventilator to provide the intended ventilation.Embodiments of the invention relate to access ports for inserting tools,valves for sealing the access ports, adapters for mating with the accessport and/or opening a valve in the access port, and instruments that canbe housed within an adapter configured to connect with the access port.Embodiments of the invention also relate to various instruments that arespecifically configured for insertion through an access port in an PPVmask using an adapter, including suction swabs, suction brushes, swabs,covered yankauers, capnometry devices, endoscopy devices, nebulizermodules, nebulizers, microphones, and the like.

Positive Pressure Ventilation Mask with Access Port

The present invention utilizes a positive pressure ventilation mask withan access port. The access port may be an opening with a removable capor a valve that can be selectively opened to attach an adapter. Theaccess port may be built into the shell (also referred to as the maskbody) of a PPV mask or into a connector (e.g., elbow) of the PPV mask.The valve may be a slit valve or a valve that seals under the pressureof the ventilator (also referred to herein as a self-sealing valve). Thevalve may also be self-reverting (i.e., made of a material and having aconfiguration that will revert back to its original configuration wheninverted by an object being pulled through the valve). The valve can bepositioned in the mask body or in a valve adapter.

FIGS. 1A and 1B illustrate a positive pressure ventilation (PPV) mask 10that includes a mask body 12 (also referred to herein as a “shell”). Asshown in FIG. 1B, ventilator system 24 includes the mask 10, access port23, and an appliance module including an adapter that connects to theaccess port 23. Ventilator system 24 also includes a ventilator unit 21that connects to inlet 30 of the elbow 26 via a flexible hose (notshown) to form a ventilator circuit. The ventilator includes a pressuresensor that senses pressure in the system and is used by control unit 15to control pressure by driving a pressure generating unit 17. Parametersof the ventilator can be displayed on display 17 and input receivedthrough a user interface (not shown). Ventilators used with the PPVmasks of the invention are preferably bi-level pressure ventilators (oralternatively continuous pressure ventilators). Bi-level ventilation istypically important for critical care patients.

Mask body 12 may be a rigid or semi rigid material. Mask 10 can includeheadgear with headgear connectors adapted to be removably attached tothe body 12. The headgear is used to secure mask 10 to the head of thepatient using upper strap 14 and lower strap 16. Straps 14 and 16connect to eyelets 18 and 20, respectively, on mask body 12. Straps 14and 16 connect to eyelets on corresponding locations (not shown) on anopposite side of body 12. The straps secure the mask to the head, whichallows a positive pressure seal to be obtained and also avoids movementof the mask relative to the head that could cause air leaks thatdiminish the positive air treatment.

At the periphery of the mask body 12, mask 10 includes a peripheralflexible cushion 22 that includes a thin flexible membrane (e.g., aflap) that can form a seal with the face of the patient when positivepressure is delivered from a ventilation system 24 through an elbow 26and into an opening in mask body 12. The cushion can form a seal withthe patient's face in a nasal bridge region, a cheek region and/or alower lip/chin region of the patient's face. The mask body 12 defines acavity (also referred to as a breathing chamber). The cushion may beconstructed of one or more relatively soft, elastomeric materialsconnected to a frame (i.e., the shell) which is constructed of a secondmaterial that is more rigid than the cushion. The cavity of mask body 12forms a positive air pressure chamber between it and the face of aperson. For purposes of this invention the term “within the mask” meansthe chamber defined by the mask when on the face of a person. The masksare configured to be fluidly coupled to ventilator 21 through air supplyconnector 26, such as an elbow.

Masks having membranes suitable for sealing around the mouth and nose ofa patient using positive pressure are described in U.S. Pat. No.9,119,931 to D'Souza, U.S. Pat. No. 9,295,799 to McAuley; U.S. Pat. No.6,513,526 to Kwok, and D464,728 to Paul, U.S. Pat. No. 6,792,943 andU.S. Pat. No. 8,365,734 to Lehman, and international applicationpublication WO2017021836A1 to Rose, all of which are hereby incorporatedherein by reference. The mask may also include an exchangeable two masksystem such as the FDA cleared AF541 mask by Respironics (MurrysvillePa., USA) and masks with similar features and function.

FIGS. 2A-2C show the elbow and valve in more detail. Elbow 26 includesan elbow body 50 formed from upper housing 52 and lower housing 54. Anaccess valve, such as cross-slit valve 42 is secured to upper housing 52using a locking ring 46. Elbow 26 also includes an anti-asphyxiationvalve that uses a flap 48 to open and close aperture 36. For purposes ofthis invention, unless otherwise stated or implied, the term “valve” byitself refers to the “access valve” in the access port 23.

Elbow 26 is an air supply connector that includes an air-deliveryconduit. The air supply conduit extends between inlet 30 and outlet 34and includes internal regions 56 a, 56 b, and 56 c (FIG. 2C). Valve 42is in fluid communication with the air delivery conduit in region 56 c.Valve 42 provides access to a wearer's mouth and nose through aperture44 and region 56 c of the conduit, thereby providing a port with directaccess to the mouth of the patient.

The air supply conduit provided by valve adapter 26 is configured todeliver pressurized air from a source of positive air pressure (e.g.,ventilator 21) to the cavity of the ventilation mask 10. Air pressure ininlet 30 forces flap valve 48 to open to provide fluid communicationbetween regions 56 a and 56 b. The air flow between region 56 a and 56 bforces flap 48 upward to close off aperture 36 by seating against seat58. If air flow stops between regions 56 a and 56 b, flap 48 drops downto opening 64 to prevent air from flowing backwards through inlet 30(i.e., from region 56 a to 56 b). Flap 48 prevents asphyxiation byallowing air to be breathed from the ambient (through aperture 36) ifthe supply of air from the ventilator is interrupted.

Elbow 26 includes a first press-fit connector 28 that serves to fluidlyconnect a positive pressure air supply hose (not shown) to inlet 30 ofelbow 26. A second press-fit connector 32 serves to fluidly connect theoutlet 34 of elbow 26 to an inlet in mask body 12. The press-fitconnection may be configured to be sufficiently tight that when anappliance is positioned in the adapter (see FIG. 9B) and pulled out ofvalve 42, the press fit maintains the connection of the air supplyconnector to the mask. FIG. 1 illustrates a mask with a swivel connector29 configured on the body of the mask 12. A press fit connector 32 isplaced inside of the swivel connector 29 and is configured to besufficiently tight to deliver air to the mask. The swivel connector hastextured finger grips 19 that are used to press on the swivel or rotatethe elbow 26.

Elbow 26 preferably swivels relative to mask body 12 such that a hoseconnected to an elbow 26 can be redirected without torqueing the mask.Any swivel mechanism can be used. The swivel mechanism may beincorporated into a mask body, elbow, or the connection there between.

Connections other than press-fit may be used to connect an elbow 26 to amask or ventilation system, including non-removable connections, screwfit with screw threads, snap connection, slide in connection withsecuring ridges, clips, and quick release connections.

FIG. 5 illustrates an embodiment wherein the elbow forms a swivelconnection with the mask. A swivel connection portion 300 is shaped tofit in an opening of a PPV mask. The swivel connector 300 is alsoconfigured with a sealing rim 304 that will seal with the edges of anopening on the mask. The elbow includes clip connectors 302 that snapinto a ridge or mount on the body of the mask to keep the elbow securelyfit and sealed on in the access port. Release tabs 306 are attached tothe clip connector that flex the clips 302 when pressed inward torelease the elbow form the mask.

With reference again to FIGS. 2A-2C, elbow 26 may also include apressure port 40 on stem 38. Pressure port 40 includes a small openingin fluid communication with region 56 b that is used to monitor pressurechanges in elbow 26. Changes in pressure can be used to detect when thewearer of the mask is inhaling or exhaling. Bi-level pressureventilators can use the pressure port 40 to provide lower pressureduring exhalation and increased pressure during inhalation. Pressureport 40 is not required to be associated with elbow 26, but rather canbe placed in mask body 12, tubing between the ventilator and mask, orcombinations of these. Pressure port 40 can be covered with a cap 39 toplug and stop flow when detection is not necessary.

Elbow 26 has an access port 23 with aperture 44 and a valve 42positioned within the port. Valve 42 may be a self-sealing valve thatuses pressure from the ventilator to close the valve when the accessport is clear of an appliance or adapter. The access valve has an opendiameter sufficient to perform oral care or insert an appliancetherethrough with reduced leaking as compared to an access port withoutthe valve and having the same maximum diameter opening. The diameter ofthe opening in the self-sealing valve (in the fully open position) canbe at least 5, 10, 15, or 20 mm (˜0.2, 0.04, 0.06, 0.08 in) and/or lessthan 50, 40, 30, 25, or 20 mm (˜2, 0.16, 0.12, 0.1, 0.08 in) and/orwithin a range of the foregoing (in the height and/or width of theopening based on a cross section of the opening). These diameters ofopening can be achieved with a valve that will be self-sealing underpressures of at least 4, 5, 8, or 10 cm H₂O and/or less than 30, 25, 20,15 cm H₂O, or within a range of any of the foregoing endpoints.

In some embodiments, the opening in access valve 42 is provided by oneor more slits. The length of the slit may provide the maximum openwidth. In some embodiments, the valve includes a plurality of slits. Insome embodiments, the valve can include two slits and the slits may forma cross-slit.

To facilitate self-sealing under pressure, access valve 42 may haveinward sloping walls or concavity that the pressure pushes against.Valve 42 may be a duck bill valve or a dome shaped valve. FIGS. 3A and3B illustrate a duckbill valve with a cross-slit. Valve 42 has a rim 58,support wall 66, and a plurality of leaflets 62 a-d. As seen in the topview of FIG. 3A the leaflets are each concave relative to the ventilatorpressure side of the valve and form fenestrations at slits 60 a and 60b. The leaflets 62 are configured to be pushed open by an appliance orappliance adapter from an outside side of the valve and pushed togetherby pressure from the inside side of the valve. The duck bill valve isshown with 4 leaflets, but may have a single leaflet (i.e., sealsagainst a rigid wall) but more preferably has at least 2, 3, 4, or moreleaflets. As shown in FIG. 3B the concavity of leaflets 62 have ageometry that meets near the center of the cross slit. For example, theconcavity of leaflet 62 b meets near point 64. When an appliance oradapter is inserted the leaflet 62 b is forced out and point 64 movesaway from the center cross, thereby opening the valve. Valve 42 can bemade from an elastomeric material with shape memory such that uponremoving the appliance or adapter, the device recovers at least aportion of its concavity such that the pressure can seal the leaflets.

Where a dome valve is used, the dome may have a tapered thickness thatis thin at a center opening and tapers to a greater thickness towardsthe edges. The taper may include a change of thickness greater than 1.2,1.5, or 2 times the thickness at a lateral edge of a fenestration/slitsas compared to a center edge of a fenestration. The taper may allow thevalve to open more easily at the center.

In a preferred embodiment, the valve reverts itself if it becomesinverted (i.e., self-reverting). For purposes of this invention, aself-reverting valve has a material and configuration that causes thevalve to return to its self-sealing position when inverted (e.g., anelastomeric material with shape memory). Thus, if an instrument ispulled out of the valve and a leaflet or other component is inverted,the self-reverting valve returns to its self-sealing position once theforce is removed. Although not required, the valve may be concave and/ormade of a silicone material (or similar polymers, elastomers, isoprene,Nitrile rubber, Butyl rubber, or silicone like material) to facilitateself-reverting. In one embodiment, the valve includes a layer ofmaterial at its center that is less than 5, 4, 3, or 2 mm thick.

The access valve 42 and/or combination of one or more of the accessvalve 42, anti-asphyxiation valve 40, and mask 12 may be configured tohave a leak rate less than 70, 50, 40, 30, or 25 liters per minute(“lpm”) and/or greater than 2, 5, 7, or 10 lpm and/or within a range ofthe foregoing when the mask is under an air pressure of at least 5, 10,15, cm H₂O and/or less than 25, 20, or 15 cm H₂O or within a range ofthe foregoing. For purposes of this invention, the leak rate is measuredat a pressure of 5 cm H₂O when measured in accordance with ISO standard17510 (2015).

In some embodiments, the valve may include a biocompatible lubricant tofacilitate insertion of appliances or appliance adapter through thevalve. The access valve and/or lubricant may also include ananti-microbial agent (e.g., chlorhexidine). In some embodiments, thevalve adapter may have a dust cap that covers the opening to valve 42the valve is not in use.

FIG. 4A shows an alternative embodiment with an elbow 426 that does notinclude the access valve 42 of elbow 26 from FIG. 1. Elbow 426 includesan aperture 44 configured to receive appliance adapters that will sealthe aperture 44 when the adapter is attached and/or placed through theaperture 44 (see FIGS. 7A-C). Because access port 23 of elbow 426 doesnot have a valve that seals the port when not in use, elbow 426 includesa seal cap 49 that can be placed over or in aperture 44 to prevent airleakage and to maintain air pressure between the mask and the face.

FIG. 4B illustrates an alternative embodiment of a mask 10 having ashell 12 b that incorporates the access port 23 into the shell 12 binstead of the elbow connector. Shell 12 b has an elbow connector 27separate from access port 23. Elbow connector 27 supplies pressurizedair to the mask and may have any features known in the art for elbowconnectors used on PPV masks. Similar to mask 10 of FIG. 1, valve 42seals access port 23 using positive pressure in mask 10. Placing accessport 23 in the mask separate from the elbow connector allows elbow 27 tobe smaller than elbow 26 of FIG. 1.

The access port in shell 12 b may also be configured without a valve asshown in access port 423 of FIG. 4A. In addition, access ports 23 (withor without a valve) can be placed anywhere on shell 12 b that allowsdirect external access to the mouth or nose of the patient (i.e., accessto the mouth or nose through the mask).

FIG. 4B also illustrates one embodiment showing a mask body 12 b with aflexible portion 106 that is more flexible than the material of theadjacent portion of mask body 12 b. The flexible portion 106 providesgreater articulation and movement for appliance adapters placed throughthe access valve 42 as well as support and flexibility in maintaining aseal around the face created by the cushion 22. The flexible portion 106of shell 12 b can also be incorporated into mask body 12A of theembodiments shown in FIGS. 1A and 4A. In an alternative embodiment, theswivel connector 29 of FIG. 1A or 4A can be configured to be moreflexible than the body of the mask 12. Flexible elbow connectors arefurther described in U.S. Pat. No. 8,302,605 which is herebyincorporated herein by reference. In yet another embodiment, the accessport may be an iris valve such as the valve described in US2003/047189to Kumar, which is hereby incorporated by reference.

Appliances, Adapters, Modules, and Kits that Maintain Positive Pressure

Some embodiments of the invention relate to appliances (e.g., scrubbrushes, suction devices, CO₂ sampling lines, nebulizers, microphones,yankauers, and bite blocks) that include an appliance adapter. Theappliance adapter can be coupled with an appliance to form an appliancemodule. The appliance adapter allows an appliance to pass through anaccess port on a PPV mask while maintaining pressure inside the mask.For instance, a suction swab appliance can be coupled with an applianceadapter to form a suction swab module (see FIG. 6A) that can be insertedinto the access valve 42 and then used to perform oral care on a patientwhile maintaining positive pressure in the mask. (as illustrated in FIG.9B)

The appliance adapter is preferably configured to work with an accessport, preferably one that includes an access valve that seals underpressure from the ventilator (e.g., the self-sealing and self-revertingaccess valves as described herein) and is configured to engage theappliance adapter to seal off the access valve. The appliance coupledwith an appliance adapter can include but not limited to a suctionbrush, toothbrush, suction tube, CO₂ sampling lines, nebulizers,microphones, endoscopy devices to form a variety of appliance modules.Providing a variety of appliance modules to a patient using one maskwith an access port or access value can be important because it may notbe known which particular procedures need to be performed on a patientwhen the mask is placed. Providing an access port or valve on a maskthat can receive a number of different appliances for differentprocedures will allow patients to receive the desired care or proceduresnecessary for their conditions. This can be done without having toremove or exchange masks or elbows, especially when removing a PPV maskor elbow is clinically undesirable.

Appliance Adapter

Sealing structures on the appliance adapter provides a sealing surfacesthat engage with and seal the adapter to both of an access port in a PPVmask and a portion of an appliance. The sealing structure may be a wall,rib, chamfered seat, membrane, gasket or other structures suitable forperforming the function of sealing adapter to an access port orappliance.

In one embodiment, as show in FIG. 7A-7C, the appliance adapter includesa housing 76 (also referred to herein as “body) that extends from anoral end 78 to a proximal end 79. The housing includes a seal surface 72(on the periphery thereof) and a housing member 74 on an interior ofhousing 76 that divides the adapter into, an outside portion 75, and aninside portion 77. Inside portion 77 extends from the seal surface 72and housing member 74 toward oral end 87. Inside portion includes thesurfaces that are on a side of the adapter that is exposed to thepressure of the ventilator when the adapter is attached to the accessport. The outside portion extends from sealing surface 72 and housingmember 74 toward proximal end 79. The outside portion of the adapterincludes those surfaces that are exposed to pressures external to themask (i.e., ambient pressures).

The sealing surface 72 is configured to form a PPV seal with an accessport (e.g., access port 23) when attached to PPV mask 10. FIGS. 7A-7Cshow the engagement of the ring structure of elbow 26 with the remainderof the access port removed for clarity. FIG. 7A shows ring 46 withadapter partially inserted. FIG. 7B shows adapter 70 fully seated andsealed with ring 46. FIG. 7C shows adapter 70 completely removed fromring 46.

As best seen by a comparison of FIGS. 7B and 7C, when ring 46 andadapter 70 are fully seated or engaged, seal surface 72 engages a wall84 and chamfered structure 85 of ring 46. The seal is formed from thetolerance of the diameter of the wall 84 and the surface of the tubularhousing 76 forming sealing surface 72. The seal may be a slidable sealwhere the seal is formed on a tubular structure that slides throughaperture 44.

In some embodiments, the seal surface 72 may be a chamfered structurethat mates with chamfer 85 of the ring. The chamfer may be formed in arib with a diameter of less than 0.1 or 0.05 inch. The length of theadapter as measured from the seal structure to an oral end of theadapter is at least 0.3, 0.6, 1.2, 2.4, or 5 inches and/or less than 8,6, 4, 2, 1.5, 1, 0.6, or 0.3 inch and/or within a range of any of theforegoing endpoints. The PPV seal may be formed between surfaces of theadapter and access port having a gap less than 0.02, 0.015, 0.01, 0.006,or 0.003 and at or greater than 0.0, 0.001, 0.002, 0.003, 0.005, 0.006,0.01 inch or within a range of the foregoing endpoints. The insideportion of the adapter may have a maximum or minimum outer diameter lessthan 3, 2, 1.5, 1.2, or 0.6 inch and/or greater than 0.3, 0.6, 0.8, 1.0,1.5 inch and/or within a range of the foregoing endpoints. Selecting aproper gap can be important for making it easy to remove the adapterfrom the access port, especially when the access port has a valve in it.In some embodiments, the adapter can form a PPV seal and the adapter canbe removed by pulling on an appliance to slide the adapter out withoutgripping the adapter.

Adapter 70 also includes an appliance aperture through which an elongatemember (e.g., a tube) of an appliance can slidably seal. The housingmember 74 may define the appliance aperture for receiving the elongatemember of the appliance. The appliance aperture 81 is configured to sealwith a portion of the appliance.

The appliance aperture may be a septum in a tube. The housing member maybe injection molded with a housing wall of the adapter, which avoids theneed for assembling a separate structure to form the seal. Applicant hassurprisingly found that an injection molded housing member with a smallaperture can form a sufficient PPV seal and allow sliding andarticulation of a tube. To ensure sufficient articulation of theelongate member, the housing member adjacent the appliance apertureshould be thin. The housing member forming the aperture and engaging theelongate member may have a maximum and/or minimum thickness less than0.5, 0.1, 0.05, 0.01 inch and/or greater than 0.005, 0.01, 0.02, or 0.04and/or within a range of any of the foregoing endpoints.

Adapter 70 may include a receptacle 86 formed on the inside portion ofthe adapter. The receptacle may provide a cover for a working headand/or may provide space for articulating a shaft of an appliance fromside to side with the working head inserted. Receptacle 86 may define acavity with dimensions as described above with regard to the insideportion of the adapter. The appliance can provide protection to anappliance when being inserted through a valve. For example, whencoupling the appliance adapter to a mask with a self-sealing valve, theappliance adapter may have a receptacle for housing a compressiblematerial, such as a sponge. The receptacle can prevent the sponge frombeing squeezed by the valve when retracting the suction swab module fromthe access valve. The receptacle may provide access through theself-sealing valve without compressing the material. (see FIGS. 9A and9B)

While the invention has been illustrated with a housing member that isintegral to the adapter body, it will be appreciated that other sealingfeatures can be used, including the sealing features described abovewith regard to the first seal. In one embodiment, the appliance adaptermay have a flexible membrane sized and configured to seal around aportion of an appliance. The flexible membrane allows the appliance tobe manipulated through a port by flexing the membrane.

The user of the device can place the application module into the accessport or access valve 42 by gripping the vertical grip tab 83 on theoutside portion 75 of the adapter 70. The receptacle 86 of the adapter70 is placed through the aperture 44 of the locking ring 46 and passesinto the access valve 42. (as shown in FIG. 9A) As the receptacle 86slides through the lock ring aperture 44 the horizontal tabs 82 contactagainst the surface of the locking ring 46 as shown in FIG. 7B. Thiscontact will form a temporary fixed platform for stability whileproviding oral care or other procedures are performed through the PPVmask. This surface contact will also provide a tactical and visualconnection and will provide feedback to the user that the adapter isproperly placed.

The appliance adapters of the present invention may also include alocking feature to releasable lock to ring 46. Any lock feature may beused, including bayonet, snap connect, press fit, etc. The lock securesthe appliance adapter to the valve adapter. The locking mechanism mayinclude male and female components on respective locking ring andappliance adapter. FIG. 8 shows an adapter 130 with tabs 132 (malecomponent) that extend laterally under lock feature 134 (femalecomponent) of ring 46 to form a bayonet lock. Male component 134 mayalso include a bump feature to engage a corresponding feature in tabs132 when lock feature is fully engaged (e.g., by twisting the tabs intothe slot. A bayonet locking mechanism is desirable because the user canstill insert the appliance adapter into the valve adapter withoutengaging the locking mechanism, if so desired. The locking mechanism isthen easily disengaged by twisting. The bayonet mechanism also has therotational mechanism transverse to the positive pressure forces actingon the membrane, which avoids the pressure causing the locking mechanismto fail.

FIG. 8 also illustrates a lock ring that can be molded with a straightpull to mold undercuts required for lock features 134. For example, ring46 includes holes 136.

FIGS. 9A and 9B show a suction sponge module passing through the lockingring 46 and into the access valve 42. As the receptacle 86 passesthrough the access valve 42 it forces slits 60 open and leaflets 62(e.g., 62 a and 62 c) to flex and create an opening in valve 42 thataccommodates the receptacle 86, and thus the sponge portion 94 housedtherein. Receptacle 86 forms the insertion portion of appliance adapter70.

The receptacle 86 has an open end opposite the appliance surface member74 and the adapter aperture 81. The open end is configured to allow thesponge or brush portion 94 (e.g., or other portions of variesappliances) of the appliance to freely pass there through. The open endof the receptacle 86 may have a diameter in a range from 5, 10, 15, or20 mm and/or less than 40, 35, 30, 25, 20, or 15 mm and/or within arange of any of the foregoing. The receptacle 86 may also extend beyondthe leaflets of valve 42 when fully inserted. FIGS. 9A and 9B alsoillustrate swivel 29 and shell 12 of mask 10. As shown in FIG. 9B,working head (sponge 94) is inserted within the mask 10 by inserting itdistally (i.e., toward the oral cavity) past shell 12. Further movementof the appliance places brush 94 inside the oral cavity of the personwearing mask 10 with the adapter attached thereto.

While some embodiments of the invention utilize a receptacle, someadapters of the invention do not require a receptacle. For instance,appliance modules that mate with access ports that do not have a valve(e.g., FIG. 4A) may not benefit from a receptacle in some cases. FIG. 10illustrates an adapter 130 that lacks a receptacle substantiallycovering the appliance head 139. Housing 140 provides a seal surface butdoes not extend towards the oral end enough to provide protection forhead 139.

Oral Care Appliances and Modules

FIGS. 6A-6C illustrate an example of a suction swab module 71 assembledwith an oral care suction swab and an appliance adapter 70. The suctionswab includes a shaft 88, a handle connector 90, and a scrub portion 94.

Shaft 88 has a suction channel 100 that extends from suction aperture 98a-c to outlet 92. The fluid pathway between suction apertures 98 andoutlet 92 is in fluid communication with the handle connector 90 andhandle connector port 95. Suction through apertures 98 can be carriedout by attaching connector 90 to a suction handle (FIG. 11A) that isconnected to a suction source.

In some embodiments, the appliance has a shaft that is longer than acorresponding traditional appliance to accommodate for the additionaldistance added by the depth of the mask, access port, and/or adapter.

With reference to FIG. 9A, in use, valve adapter 70 is in fluidcommunication with mask body 12 at region 56 c and in fluidcommunication with a positive air supply from a ventilator at inlet 30and flap valve 48 moves upward to open the conduit between inlet 30 andoutlet 34.

Scrub brush appliance 80 can be advanced into the mouth of a patientthrough region 56 c of valve adapter 26 while membrane 74 creates a sealaround shaft 88 of suction brush 80. Because receptacle 86 does notfully occlude the space in region 56 c, airflow and thus positivepressure can continue to pressurize the chamber between the mask and theface of the patient. Fluids can be delivered to the mouth in sponge 94and suction can be used to remove the fluids from the mouth throughsuction brush 80. Suction brush 80 can be manipulated in differentdirections, while still keeping a relatively good seal.

To remove sponge 94, scrub brush 80 is retracted until sponge 94 isagain housed within receptacle 86. Valve adapter 70 is removed fromvalve 42 and valve 42 self-seals from the positive air pressure withinregion 56 c pushing against leaflets 62 of valve 42, thereby causingslits 60 to close. If the user does not fully retract sponge 94 intoreceptacle 86 and the sponge catches on leaflets 62 and caused the valveto invert, the configuration of the leaflets 62 and the resilientmaterial cause it to revert itself (i.e., self-reverting) underpressures described herein for positive pressure ventilation.

Oral Care Suction Handle

FIGS. 11A-C illustrate an example embodiment of a suction handle 122configured for use with a suction appliance 104 such as swab brush 80.Suction handle 122 includes an appliance connector 124 on a distal endof handle 122 and a suction connector 126 on a proximal end of handle122. A fluid channel 132 extends between connectors 124 and 126 fordelivering fluids towards suction connector 126. Slider switch 128 ismovable between two positions (shown closed in FIG. 11B and open in FIG.11C). A flap 134 extends across channel 132 in the closed position (FIG.11B). In the open position, the slider is moved forward and flap portion134 is no longer across the channel, thereby providing an open conduitfor suctioning fluids. Another embodiment of the invention relates to anappliance handle that include both an on-off switch and a suction port(e.g., thumb port) (not shown). FIG. 11C shows the position 136, where achannel normal to channel 132 can be formed to place a suction port inhousing 130 in front of slider button 128. The on-off switch allows thesuction to be turned off when the device is not in use, but connected toa source of suctioning. The suction port allows the user to toggle thesuction on and off during use by covering and uncovering the port.Suction to the patient is off by default when the port is not covered bya finger or other object. The default off position is created by theshorter path length to the suction port compared to suctioning throughconnector 126. When the suction port is occluded by a finger or otherobject, suction is transferred to the connector 126.

Suction Brush Module

Some embodiments of the invention relate to a suction brush module 140.Module 140 includes a brush appliance 142 that includes an elongatemember in the form of an extruded tube 143. Tube 143 is connected on aproximal end to suction connector 146 and at a distal end (i.e., oralend) to a brush head 148. The brush head 148 is housed in an adapter 144configured to connect to and form a seal with port 23 of mask 10 (FIG.1A).

Tubing 143 includes a bend 145 that allows for greater articulation whenthe brush head is inserted into the mouth of a patient wearing mask 10with module 140 attached thereto. Tube 143 may have a constant outerdiameter to facilitate sealing between the tube 143 and an aperture ofadapter 144 as described above. Brush head 148 is housed in a receptacleof adapter 144 and is slidably connected to adapter 144 in the samefashion as suction swab module described above (FIGS. 6A-6C and 9A-9B).

FIGS. 12B and 12C illustrate brush head 148 in more detail. Brush head148 has a plurality of bristles closely spaced on a surface 170 of headbody 154. Bristles can be of the type placed in head 154 oralternatively can be a single injection molded part with head 154.Methods for injection molding bristles is disclosed in US20090007357 toMeadows, which is hereby incorporated by reference in its entirety. Asponge is attached to head body 154 opposite bristles 150. A tubingconnector 152 is formed into head 154 for connecting tubing 143. Tubing143 can be press fitted, glued, solvent bonded, or connected using anysuitable joining method. Connector 152 has an upper portion 168 that israised above surface 170 to allow the tubing to be more centrallylocated. Tubing connector 152 can have a depth of at least 0.05, 0.1,0.15, or 0.2 and/or less than 0.5, 0.3, 0.25, or 0.2 inch or within arange of any of the foregoing endpoints.

FIG. 12C shows a cross section of brush head 148. Brush head 148 mayinclude a plurality of suction ports, including suction port 158 at anoral end (i.e., distal end) and a second suction hole 160 that passesthrough sponge 156. The suction holes are in fluid communication withsuction tubing attached to connector 152. The fluid channel from holes160 and 158 can be connected through a lofted or upward angled portionof the channel 162.

Connector is preferably positioned centrally relative head 148 tofacilitate placement of the head within the receptacle of the adapter144. The head 148 has a midpoint 164 and the connector 152 has alongitudinal axis 166 that is aligned with midpoint 164. In someembodiments, the longitudinal axis of the tubing connector is off centerfrom the midpoint of the brush head by less than 30%, 20%, 10%, or 5% inwidth and/or height (where the height is the dimension shown in FIG. 12Cand the width is normal to the cross section shown).

Covered Yankauer

Some embodiments of the invention also relate to a covered suctionmodule (e.g., Yankauer) that has an adapter configured to connect withan access port of a positive pressure ventilation mask. Suction module172 includes a suction appliance 174 slidably connected to a suctionappliance adapter 180. Suction appliance 174 includes a tube 176 with aplurality of bends 178 a-b. Tube 176 is connected at a proximal end tosuction connector 184 for connecting the suction device to suctionhandle or other source of suction. A sheath 182 (also referred to hereinas a cover) is connected to adapter 180 and connector 184. Sheath 182 isbunched due to the adapter 180 being pulled back to expose the workinghead (suction tip 188). Sheath 182 is welded to connector 184, but canalso be connected by other means such as tape or a physical connectionsuch as a snap connect that pinches the sheath.

Suction tip 188 includes a plurality of suction holes 190 a, 190 b, and190 c (190 c not shown). Suction head also includes retention features(ribs 192 a-c) that retain tip 188 in receptacle 204 of adapter 180 whenplaced in the retracted position as shown in FIGS. 13B and 13C. FIG. 13Bis a cross section showing tip 188 in greater detail. Ribs 192 a and 192c are shown with an interference fit to housing member 198, which formsa ring around tip 180 and engages the ribs 192 to provide a desiredlevel of retention. In some embodiments, the tip 188 includes aplurality of ribs. Additional ribs may be used to provide greaterstability in the aperture of housing member 198 or to increase theresistance to unwanted pull out. Ribs 192 may have a sloped surface 202that smooths out the transition of the ribs to the housing member 198,which creates the interference to resist pull out. A stop feature 200can also be placed on tip 180 to avoid tip 180 from being pulledcompletely through the aperture of housing member 198.

Sheath 182 provides a cover for tubing 174 when the sheath is in theretracted position. Sheath 182 may be connected to the adapter 180 usingan insert 194 and clamp ring 196. Insert 194 is configured to connectwith the wall of the adapter. Sheath 182 is positioned over a portion ofinsert 194 and clamp ring 196 is applied to clamp sheath 182 to insert194. Bumps 218 on clamp ring 196 engage a bump on insert 194 to providea friction fit or a “snap on” feature that clamps an end of sheath 182onto insert 194 and retains the sheath on adapter 180.

FIG. 13C shows suction module 172 in a covered position. In the coveredposition, tip 188 is housed within receptacle 204 and sheath 182 isextended. In the covered position module 172 can be placed on a surfaceand tip 188 is protected from contacting the surface and beingcontaminated or contaminated the surface. Module 172 can be stored bythe bedside of the patient and when needed tip 188 can be ejected fromreceptacle 204 by advancing connector 184 toward adapter 180 to releasethe tip 188 from housing member 198 and compressing sheath 182.

FIG. 14 illustrates an alternative embodiment of the sheath and adapterof a suction device. Suction module 220 includes an adapter 206configured to form a seal with an access port of mask 10. Adapter 206includes a tubular grip 216 on an outside portion thereof. An endportion 214 of sheath 208 is attached on the outside surface of tubulargrip 218. The attachment may be a heat weld, tape, or any other suitableconnection. End 212 is adhered to suction handle connector 212. Theconnection may be a heat weld, tape, or any other suitable connection(e.g., pinch fit like insert 194 and ring 196 of module 172).

The foregoing suction devices may have adapters with any of the featuresdescribed herein and may be used on access ports that have a valve or donot have a valve.

Capnometry

Some embodiments of the invention relate to capnometry systems thatinclude a capnometry module having an adapter that connects to an accessport of a PPV mask (e.g., mask 10) and allows a capnometry sampling lineto be introduced into the mask and/or oral cavity of a patient wearingthe mask. The capnometry module can be used to accurately sample endtitle CO₂ while maintaining ventilator pressure and deliver the CO₂sample to a capnometer for measuring end title CO₂ concentration.

FIG. 15A illustrates a capnometry module 222 including an adapter 224that is configured to attach to an access port of a PPV mask. Theadapter can have any of the features of appliance adapters describedabove and can be used with any access port as described above (e.g.,with or without a valve). Module 222 includes a capnometry appliance226. Capnometry appliance 226 has a support housing 228 that supportsand houses an inside sampling line 230 a that is contiguous with anoutside sampling line 230 b (referred to collectively as sampling line230). A casing 232 is positioned at an oral end of housing 228. Casing232 defines an inlet that forms the most distal portion of sampling line230.

Casing 232 also includes openings at the oral end that are in fluidcommunication with an interior of support housing 228. Housing 228includes a series of holes (e.g., the series of six holes ending withhole 234) that allow air to enter and exit housing 228 and serve as aby-pass for air.

The porosity provided by holes 234 and 250 allow a patient to breathwhile pursing their lips around housing 228 during use. Holes 234 areconfigured to have at least one hole positioned outside the mouth of thepatient and within the mask when attached thereto and in use, such thata patient can breathe through support housing 228 with their mouthclosed around housing 228. Air traveling in holes 250 or a portion ofholes 234 positioned within the mouth deliver air through housing 228and into the mask through the portion of holes 234 outside the mouth butinside the mask. Testing has shown that the best CO₂ sampling occursfrom sampling with the lips closed around the outer tubing and exhalingthrough the by-pass holes while maintaining pressure in positivepressure mask.

Adapter 224 includes a tubing portion 236 on an outside portion thereofthat is used to connect a distal end 240 of a sheath 238. Sheath 238 canbe heat welded, taped, or otherwise connected to tubing portion 236. Aproximal end 242 of sheath 238 is attached to proximal connector 244using any suitable connection such as heat welding or tape. Connector244 forms a seal with external tubing 230 b. External tubing 230 bincludes a sampling line connector 246 that connects to a capnometrysystem suitable for measuring end title CO₂ (not shown). Connector 246can be a press fit, luer lock, proprietary connector, or any suitableconnector for attaching a capnometry sampling line to a capnometrysystem that can accurately measure CO₂. An example of a suitablecapnometry system that can be used with the module 222 of the presentinvention is illustrated in U.S. Pat. No. 5,957,127, which is herebyincorporated herein by reference in its entirety. Another example of acapnometry device that can be attached to the capnometry appliancemodule 222 is Capnostream™ 35 Portable Respiratory Monitor, byMedtronic™ (Minneapolis, Minn.).

In an alternative embodiment, the capnometry system can be incorporatedinto the support housing 228 on a proximal end thereof or an outsideportion. An example of a capnometry system incorporated into the housingis illustrated in US Patent No. 2005/0245836, which is herebyincorporated herein by reference in its entirety. An additional exampleof a capnometry device that can incorporated into the support housing228 of the capnometry appliance module 222 is the EMMA MainstreamCapnometer, by Masimo, Inc. (Irvine Calif.).

FIG. 15B is a cross section of the capnometry module of FIG. 15A showingthe connection between adapter 224 and support housing 228. Adapter 224includes an aperture 229 that slidably seals against support housing228. Support housing 228 can have a relatively constant diameter toallow the housing 228 to slide along aperture 229 and maintain a seal.Preferably the gap is in a range as described above with reference toother appliances of the present invention. FIG. 15B shows working head(casing 232 with inlet 248) in a retracted or covered position (i.e.,withdrawn into receptacle 231 of adapter 224. With inlet 248 in thecovered position, sheath 238 is extended (i.e., no longer bunched orless bunched). In the covered position, a portion of holes 234 areproximal to the aperture 229, which forms the seal with housing 228.However, sheath 238 can be sealed such that pressure in the mask ismaintained by aperture 224.

As shown in FIG. 15B, casing 232 supports line 230 in a central positionwithin housing 228. This position is beneficial to avoid saliva frombeing sucked into port 248. Other configurations of inlet 248 can beused where the inlet is internal to the support housing. The inlet tothe sampling line may be positioned near the oral end of the housing byless than 50, 25, 10, or 5 mm or greater than or equal to 0, 5, 10, 15mm and/or within a range of the foregoing.

FIG. 16A is a cross section of a capnometry module 223 according to analternative embodiment of the invention. Module 223 includes a supporthousing 228 with a sampling line 230. Casing 232 shows holes 233 forallowing gas to flow into housing 228. Module 223 is shown in theretracted or covered position. module 223 includes an insert 241 andclamp ring 237 that attaches sheath 235 in a similar fashion asdescribed above with regard to the yankauer insert.

FIG. 16B describe a capnometry module 247 with a fixed housing 245relative to adapter 249. Fixed housing 245 is coupled to a housingconnector 251 of adapter 249. Connector 251 also includes an aperture253 a through which sampling line 230 passes. Sampling line and aperture253 a form a PPV seal. Adapter 249 also has a seal structure 253 b thatforms a seal with access port 23 of mask 10. The length of housing 245is configured to place the oral end 245 a within the mouth of a patientwhen attached to access port 23 of mask 10. Housing 245 is configured tobe inserted through a self-sealing and/or self-reverting valve (e.g.,valve 42) or may be introduced through valve or other port in the mask,such as a port with a removable cap (FIG. 4A or 4B).

In the foregoing embodiments related to support housing, the housing hassufficient rigidity to be inserted into the mouth. In some embodiments,the housing may be sufficiently rigid to serve as a bite block toprevent a patient from biting through the sampling line. The supporthousing may have a bend to follow the contour of the mouth or place theinlet near the roof of the mouth of the patient. In some embodiments thesampling line may have a fluid filter for blocking water and allowingthe flow of gas.

Some embodiments of the capnometry devices of the invention relate tothe use of the ventilator display for outputting CO₂ measurements usingthe capnometry modules of the invention. In this embodiment, readingsfrom the capnometry module are received by the ventilator unit 21 anddisplayed on display 19.

The present invention relates to software systems in capnometers,nebulizers, and/or ventilators. The ventilation systems may capture aseries of end tidal CO₂ readings over a period of time. The series caninclude at least 3, 5, 10, or more readings. Periodicity may be greaterthan 0.25, 0.5, 1.0, or 2.0 hours and/or less than 24, 12, 6, 3, or 1hour, or within a range of the foregoing. The change in CO₂concentration may be plotted on a screen typically as mmHg or otherpressure. The computer-generated plots can include concentrationthroughout several breaths or may be a graph of end title CO₂ and/or maybe a graph of end title CO₂ measurements taken intermittently. Theventilator or capnometer may include a warning indicator for thresholdparameters that are exceeded relative to the capnometry (e.g., rate ofCO₂ increases or decreasing or passing an absolute threshold).

The capnometry sampling line adapter can be used with positive pressureventilation at pressures greater than 4 cm H₂O and bi-level ventilation.U.S. Pat. Nos. 8,146,591, 5,957,127, and US application publication2012/0272962 describe capnometry systems that can be modified accordingto the present invention to provide CO₂ measurements of a patient onpositive pressure ventilation mask. Ventilator system 24 may include anelectrical cord that extends the length of ventilation circuit 11 fromventilator unit 21 to mask 10 for use in receiving capnometry readings.The electrical cord may also be used for receiving speech readings froma microphone and/or for performing nebulization.

Endoscope module: The appliance adapter may be an endoscope adapter thatincludes a sealing structure (e.g., gasket, membrane, or appropriatelysized aperture) configured to form a seal with an endoscope. Theendoscope may be used to perform an esophagogastroduodenoscopy (EGD)procedure while maintaining pressure in a mask. The opening in theappliance adapter for accommodating the endoscope may be at least 8, 10,or 12 mm and/or less than 15, 13, or 11 mm and/or within a range of anyof the foregoing maximum and minimum dimensions.

The foregoing masks, valves, modules, and/or appliances can be used toprovide an oral or nasal care system for cleaning the oral or nasalpassageways of a patient on a positive air pressure ventilation mask.

While the appliance adapters of the present invention have beenillustrated with a self-sealing, self-reverting valve, unless otherwisestated, embodiments of the invention also include performing oral accessprocedures under pressure with appliances and appliance adapters thatare configured to attach to a port with a mere aperture and a removablecap or the like. (see e.g., aperture 22 of US Patent applicationpublication 2010/0116276 to Bayasi).

The appliances described herein may be packaged with the applianceadapter and/or be assembled and/or packaged together. In the case wherethe seal between the appliance adapter and the appliance is specific tothe appliance, the appliance adapters typically needs to be preassembledwith the appliance. For example, a suction brush may have a handle onone end and a sponge brush on the other end of a tube and the seal needsto engage the tube. In some cases, pre-assembly of the appliance adapterand corresponding appliance is necessary to avoid the need to find thecorrect adapter when performing a particular procedure. For instance,when performing an endoscopic procedure an appliance used to introduceanesthetic is best assembled with the adapter to avoid the situationwhere a practitioner needs to use the appliance to introduce anestheticand does not have an appliance adapter readily available. Nevertheless,when the appliance is expensive and non-disposable (e.g., an endoscope),the integration of the appliance adapter may not be practical, despitethe advantage of doing so.

Intubation Adapter

Another embodiment of the invention relates to adapters and modules forperforming camera-based procedures through a mask. Examples includebronchoscopy, esophagogastroduodenoscopy (EGD) procedure, andintubation. The adapter includes a seal structure for sealing withaccess port 23 of mask 10. FIGS. 17A and 17B illustrate an exampleadapter 255 with an adapter body 257 and a membrane 259 that has a slitvalve 261. Slit valve 261 is configured to receive an endoscopy deviceand seal around its perimeter as it is inserted and retrieved from thebody of the patient.

Membrane 259 may be a flexible or elastic material. Membrane 259 may besufficiently elastomeric (e.g., a polyurethane) to allow stretching toplace different sized endoscopes while still forming a seal. Themembrane may have a hole size that accommodates or stretches to aparticular diameter camera (e.g., 5, 6, 8, 10, or 12 mm camera) (orwithin 1, 2, 3 mm of a traditional camera size). The membrane may alsohave cross slits to allow a device to be pulled through with more ease.

Membrane 259 may be attached to a bump or annular ridge 267 of adapter257. A rim 265 of membrane 259 can be adhered (e.g., solvent bonded) tothe adapter wall. membrane 259 has a thin region 263 that facilitatesflexibility when an instrument is inserted into slit valve 261. Thoseskilled in the art will appreciate that there are other types of valvethat can be configured within adapter 257 to form a seal around anendoscopic device.

The endoscopic modules of the invention can have adapters with any ofthe features of adapters as described herein and can be used with anyaccess ports and masks as described herein.

FIG. 18 shows an alternative embodiment of a membrane 273 that is formedfrom over-molding the membrane with an adapter having holes where thevalve material can flow through. Over molded membrane 273 includes aplurality of connecting members 273 that attach rim 271 above and belowa protrusion.

Nebulizer

The present invention also relates to adapters, appliance modules andmethods for nebulizing a patient on non-invasive positive pressureventilation (PPV). The nebulizer adapters and nebulizer appliancemodules of the present invention can deliver aerosols to the oral cavityof an PPV patient while maintaining pressure and without disconnectingthe ventilator circuit to attach the nebulizer.

In a first embodiment, the nebulizer adapter may be an elbow connectorthat seals with an access port 23 of a mask 10 and connects to atraditional nebulizer. The nebulizer adapter can have any of thefeatures of appliance adapters described above and can be used with anyaccess port as described above (e.g., with or without a valve).

The first nebulizer embodiment is illustrated, for example, in FIGS.19A-19B. Nebulizer adapter 260 connects to an access port 23 of a mask10 and connects to a traditional nebulizer. An example of a traditionalnebulizer that can be connected to the nebulizer adapter 260 isillustrated in U.S. patent Ser. No. 10/833,932, and is incorporatedherein by reference in its entirety. The traditional nebulizer thatconnects to the nebulizer adapter 260 can include a micro vibratingelement portable nebulizer, an ultrasonic nebulizer or a piston pump jetnebulizer. The nebulizer adapter 260 is configured with an insideportion 270 that can be placed through an access port 23 of a PPV mask10 or an access valve 42 in a port of a PPV mask. The inside portion canbe made of a tubular body 262 that defines a tubular chamber 268 that isin fluid connection with a mouthpiece 264. The mouth piece 264 extendsfrom the tubular body 262 and it can be connected by a lock ring 266 orother suitable locking mechanism. The mouthpiece 264 can be removed andexchanged prior to use to allow patients to fit a correct sizemouthpiece onto the nebulizer adapter 260. In other embodiments, themouth piece 264 can be integrated and connect to the tubular body 262with a pressure fit mechanism or snap fit connections. The tubular body262, is placed within the mask or into the mouth of the patient. Thepatient places their lips onto the surface of the mouth piece 264 andcan receive treatment from the nebulizer while maintaining ventilationpressure within the mask. Nebulizer adapter 260 can also include anoutside portion 272 that is separated by rim 274. Rim 274 can seal witha port 23 having a valve 42, as described above in other appliancemodules and adapters. Tabs 276 can be positioned near rim 274. toconfigure the nebulizer adapter to seal with the valve or port, asdescribed above in other appliance modules.

The outside portion 272 continues the tubular chamber 268. The outsideportion 272 is configured with an inlet port 280 (and cap 282) forreceiving a traditional nebulizer and is in fluid communication with thechamber 268. A liquid medicament passes through the traditionalnebulizer and generates an aerosolized medicament that passes throughthe inlet port 280 and through tubular chamber 268, and mouthpiece 264.Mouthpiece 264 may be sealed with the users lips and the user breathesin and out slowly. Breathing is continued until the aerosol formationhas stopped and the medicament in the traditional nebulizer has beendelivered into the patient's respiratory system. The traditionalnebulizer is then removed from the inlet port 280 and the nebulizeradapter 260 is removed from the access port 23 and/or valve 42.

In a second embodiment, a nebulizer appliance module 250 includes anebulizer. The nebulizer appliance module 250 is configured to beinserted into an access port 23 and/or a valve 42 of a PPV mask 10. Whenthe nebulizer appliance module is inserted into the mask 10 aerosolmedicaments can be received directly into the mask and/or mouth of theuser while receiving ventilated air in the mask. This embodiment, asdescribed in other appliance modules above, will maintain ventilationpressure in the mask while the appliance module is in use. Whendelivered into the mouth, less medicament will collect on the surfacesof the mask and instead a high percentage of medicament is delivered tothe user.

FIGS. 20A and 20B illustrate an embodiment of a nebulizer appliancemodule 250. The nebulizer appliance module includes an adapter body 252that defines an inner fluid reservoir 254, a module chamber 280, asealing rim 256, and a mouthpiece 258. In an alternative embodiment, themouthpiece 258 can be removable and exchangeable. The mouthpiece 258 isconfigured to connect to the inner tubular portion 254, as described inthe nebulizer adapter 260 above. The inner fluid reservoir extends fromthe inner portion and the outer portion of the adapter body 252. Thefluid reservoir has an opening or inlet port 282 configured to receiveliquid medicament and has a reservoir cap 278 configured to seal theinlet port 282 of reservoir 254. Reservoir 254 can hold a liquid volumeof at least 2 ml, 4 ml, 6 ml, 8 ml, or 12 ml and/or less than 50 ml, 30ml, 25 ml, or 20 ml, and/or within a range of the forgoing endpoints. Amodule chamber 280 houses a battery 286, circuit board 288, controllerleads 296, and a fluid sensor 284. The fluid sensor is in fluidcommunication with the reservoir 254 and is configured to turn off thepower to the aerosol generator 294. The aerosol generator is at or nearto the distal end of the adapter body 252 and is in fluid communicationwith the inner fluid reservoir 254. The aerosol generator 294 comprisesa vibratable member 300 (such as a micro vibrating element) and apiezoelectric element 302. The vibratable member 300 and piezoelectricelement 302 can have a plurality of tapered apertures extending betweenthe upper and lower section of the distal end of the adapter body 252.

FIGS. 20A and 20B illustrate a simplistic view of a nebulizer circuity,parts, and connections. A Power switch 292 and LED 290 indicator arelocated on the proximal end of the adapter body 252. See U.S. patentSer. No. 10/833,932 for a detail description of the circuity, parts, andconnections of a micro aerosol generator system, which is herebyincorporated herein by reference.

The input from the power switch 292 is received by a control unit 304 onthe circuit board 288. The circuit board 288 uses the input to turn onand off the aerosol generator. The aerosol generator causes thepiezoelectric element 302 to vibrate the vibrating member 300.

This vibration of the vibratable member 300 causes the liquid medicamentto pass through the apertures of the vibrating member 300 where themedicament is aerosolized by the ejection of small droplets ofmedicament. The aerosolized droplets of medicament flows through themouthpiece 258 and into the oral airway to be received by therespiratory track of the user.

A nebulizer system can be powered by a battery 286 that is housed in themodule chamber 280 or it can be powered by a controller that plugs intoa nebulizer system on the proximal end of the adapter body 252. FIG. 21illustrates a nebulizer appliance module 310 that is configured with acontroller connector 298 and is configured to receive a control signalfrom a controller (not shown).

The nebulizing fluid can be delivered to the patient in coordinationwith the inhalation of the patient. Delivery of the medicament duringinhalation can be controlled by varying the carrier gas. At the time orjust before the patient inhales, the carrier gas pressure can beincreased to cause an increase in nebulization and then decreased onexhalation. In some embodiments the carrier gas pressure is varied usingthe pressure variation delivered by a bi-level ventilator. In someembodiments, the timing of the carrier gas delivery can anticipate thetime needed to cause nebulization to flow into the mask or oral cavitycoordinated with when the next inhalation in expected to happen.

Microphone System

FIG. 22 illustrates a microphone system 699 that includes a ventilatorsystem 624 including mask 610, access port 623, and a microphone module700. Microphone module 700 includes an adapter that connects to theaccess port 623. Ventilator system 624 also includes a ventilator unit621 that connects to inlet 630 of the elbow 626 via a flexible hose (notshown) to form a ventilator circuit 611. The ventilator includes apressure sensor that senses pressure in the system and is used bycontrol unit 615 to control pressure by driving a pressure generatingunit 617. Parameters of the ventilator can be displayed on display 617and input received through a user interface (not shown). Ventilatorsused with the PPV masks of the invention are preferably bi-levelpressure ventilators (or alternatively continuous pressure ventilators).Bi-level ventilation is typically important for critical care patients.

FIG. 23 describes a hardware layout for microphone system 699 includinga microphone module 700 and a powered audio processing system 750. Theaudio processing system may output to a loud speaker 706. Loudspeaker706 may be a bedside. Bedside speaker can be advantageous when placednear the patient because the origination of the sound will be morelikely to sound like it is coming from the person in the bed (i.e., morenatural). More natural speaking can be important to critically illpatients since they are frequently at end of life and desire tocommunicate with loved ones for the last time.

Module 700 includes the plurality of microphone elements, preferably atleast two microphones. The audio processing system 750 includes amicrophone preamplifier 752, analog to digital converter 756, digitalsignal processor 708, digital to analog converter 758, power amplifier704, system microprocessor 760, power supply 710, power on/off switch762, volume up and down buttons 764 a and 764 b, power indicator LED766, and a signal output 712.

FIG. 24 is a cross section of a mask 610 and mic module 700. FIG. 24shows an adapter 718 that has an extension housing 718 that extends thehousing of the adapter in the distal direction (i.e., toward the oralend). At the oral end, the extension housing 718 has an opening 720 thatfaces the mouth of a person when the adapter is positioned in mask 610.

Adapter 718 and its extension housing 718 can disconnect for placingcomponents of the microphone module into the housing and assembling thehousing around the microphone module components (e.g., a press fit or asnap connect. The housing is preferably configured to place themicrophone within the cavity of the mask close the patient's mouth,which has been found to be important in some embodiments for obtainingsuitable signal to noise ratio for performing accurate digital signalprocessing.

The length of extension housing 718 is selected to place the openingnear the mouth. Preferably less than 3, 2, 1.5, or 1 inch and/or greaterthan 0.25, 0.5 or 1.0 inch and/or within a range of the foregoing. Thelength of the adapter and housing as measured from the opening of theaccess port to the oral end of the microphone module may be greater than1, 1.5, 2, 2.5, 3 inch and/or less than 6, 5, 4, 3.5, 3, 2.5, or with arange of the foregoing.

Adapter 716 is positioned in the access port which extends from ring 646and opening 664 of elbow 626. Microphone module 700 extends throughopening 664 so as to place the microphone beyond mask body 612 and itsadjacent structure, swivel 632. Moving the microphone out of the opening664 and/or away shell 612 has been found to substantially improve thesignal to noise ratio. In one embodiment, the adapter is configured tocouple with the access port and place the opening to the microphone 720at least 0.25, 0.5, 0.8, or 1.2 inch inside the mask from the centerpoint of opening 664 (i.e., the inside opening of the access port). Theopening 720 of microphone module is preferably facing a mouth region ofthe person so as to receive direct sound from speech from the mouth.

A plurality of microphone elements 726 a and 726 b (collectively 726)are mounted on circuit board 722. Microphone elements 726 can be anelectret or a MEMS. Electrets can be preferred for their high soundpressure levels, which has been found to be important in the NIV Maskenvironment. MEMS can be preferred for minimizing size of the module andavailability of bottom firing elements. The microphone element may be anomnidirectional microphone or a directional microphone. Preferredelements have a high dynamic range and/or high sound pressure level.Digital MEMS (a/d converter on mic board) are also suitable, which canbe used to reduce electrical noise from hospital equipment placed nearthe bedside. Digital MEMS may also be useful for having more microphoneelements with fewer wires since the signals from different elements canbe transmitted on the same wire. In some embodiments the microphoneelement may be an active mic (power sent to the mic). The microphoneelement may also have its own pre-amp before the preamp in the audioprocessing system. A pre-amp on the microphone can reduce clipping ofthe microphone, which can be a particularly difficult problem with voiceamplification on positive pressure masks due to the increase inpressure. Although not preferred, some embodiments can use a singlemicrophone element. Noise cancellation with a single microphone elementcan require additional computation power. Noise cancellation can beperformed using the frequency domain to identify non-speech elements ofthe signal.

Preferred embodiments of the system use two or more microphone elements.The two or more elements can perform processes where coincident signalsare useful, such as in discriminant noise cancellation. Two microphoneelements may be mounted on a board and/or within housing. The microphoneelements may be differently specified microphone elements or preferablyidentical specification mic elements. The mic elements may be mounted inthe same plane, off plane, and/or at different angles. Same planemicrophones may facilitate manufacturing while differently angledmicrophones may provide better discernment of off-axis signals.Detecting off-axis signals can facilitate detecting turbulent vscoincident sounds.

In a preferred embodiment the microphone has a relatively high max soundpressure level. The closeness of the microphone in the mask and therelatively high pressure in the mask causes surprisingly high soundlevels even for patients talking moderately loud or quietly. Themicrophone module may include a sound attenuating material create aneffective sound pressure level that avoids microphone clipping for aperson talking at 50, 60, or 70 db. For purpose of this invention,unless otherwise indicated, effective sound pressure level is the soundpressure level of the microphone plus the decibels by which the soundattenuating material attenuates sand. The sound attenuating material mayhave a thickness and/or a density that prevents clipping of a microphonein the housing when placed in the mask. The sound attenuation of a foammay depend on its density and thickness. The thickness may be

An example of a suitable electret may have the following specificationsplus or minus 5%, 10%, or 20% for any: −42±3 dB RL=2.2 kΩ Vcc=2.0 v (1kHz 0 dB=1 v/Pa) Impedance Max. 2.2 kΩ 1 kHz (RL=2.2 kΩ) Frequency50-12000 Hz Current Consumption Max 0.5 mA Operating Voltage Range1.0-10 V Max SPL (dB) 120 dB S/N Ration More than 58 dB SensitivityReduction 2.0-1.5V Variation less than 3 dB Storage Condition −20˜+60°C.; R.H.<45%˜75% Operating Condition −10˜+45° C.; R.H.<85%.

In a preferred embodiment the microphone element has a diameter lessthan 0.8, 0.5, 0.3, 0.25, 0.2, 0.15 and/or greater than 0.03, 0.05, 0.1,or 0.15 inch and/or within a range of the foregoing. The microphoneelements may be a directional microphone or an omni directional.Microphone elements 126 are selected to have a low self-noise, a highmax SPL, and/or a high dynamic range and/or a small size. For purposesof this invention, the SNR is measured with a standard referencepressure of 94 dB SPL (1 Pa) at 1 kHz. In one embodiment, the dynamicrange is at least 80 db, 85 db, 90 db, or 95 db, the SNR is at least 60,65, or 70 db and/or the sound pressure level of the microphone elementis at least 80, 85, 90, 95, 100, 105, 110, 115, 120 and/or less than160, 150, 140, 130 or within a range of any of the foregoing endpoints(at the conditions set forth above for the suitable electret).

Module 700 can include an attenuator 724. Placing the microphone closeto the patient's mouth can cause excessive gain or clipping of themicrophone. To reduce the power of the vocalization, a sound attenuatingmaterial can be placed between the mic elements and the mouth of thepatient. The sound attenuating material may be a dense or thick foam. Ahigh dynamic range microphone placed near the mouth and attenuated canproduce a signal that is suitable for processing in a digital signalprocessor. In one embodiment the attenuator may be a foam with a densityof at least 2, 2.5, 3, 4, or 5 lb ft³ or less than 10, 8, 7.5, 7, or 6lb ft³. In a preferred embodiment, attenuator is a biocompatible foam.Traditional foam windscreens typically have a density less than 2 lbsft³, has been found to not be sufficient to attenuate the power of thevoice when using a high dynamic range or high max SPL mic placed nearthe mouth in a PPV mask. In one embodiment, the attenuator reduces thesound pressure level across the attenuator by at least or less than 3,5, 10, 12, 15, or 20 db or a range thereof.

Wires 728 connect board 722 with jack 730. Jack 730 is mounted to thebody of adapter 716 and is in electrical communication with cableconnector 732 and cable 701 is inserted into jack 730 and extends in theproximal direction away from jack 730. Jack 730 may form a PPV seal withadapter to maintain pressure in mask 610. Alternatively cable 701 can bemounted in adapter 701 and electrical coupled to mic elements 726 insideadapter 716. Or as described below, the seal can be between board 722and extension 718 of adapter 716.

In some embodiments, most or all of the electrical components areisolated from the distal opening of the microphone housing to preventventilation gases from reaching the isolated electrical components. FIG.25A shows an extension housing 718 with a cavity 737 bounded by circuitboard 722 and walls of extension 718. Cavity 737 has an opening 720 atthe oral end. Microphone elements 726 a and 726 b are disposed withincavity 737 as well as an attenuator material. Circuit board 722 can besealed to annular feature 134 on the wall of extension housing 718. Anytechnique can be used to form the seal including press fit, heat weldingadhesion, snap connects and any other connection suitable for use withconnecting a board to a housing. Cavity 737 may be coated with abiocompatible polymer prior to or after mounting microphone elements 726a and 726 b. Microphone elements can be connected with pins that aresoldered to form solder bumps 736.

FIG. 25B illustrates an embodiment of a sealed microphone cavity similarto FIG. 25A but with bottom firing microphones. Board 738 is mounted orsealed to housing of extension 748 to form cavity 746. Microphoneelements 740 a and 740 b are mounted on the proximal side of board 738opposite cavity 748 and opening 720. Holes (e.g., hole 742) are formedin board 738 to allow sound entering opening 720 to pass through board738 and into the bottom of elements 740. Microphone elements 740 may beflow soldered to board 738 prior to being secured in extension 746.Cavity 746 may be sealed with a biocompatible coating prior or aftermounting bottom mount microphone elements 740 a and 740 b.

FIG. 26 illustrates yet another alternative embodiment of a microphonemodule 768. Module 768 includes an adapter 770 with an extension housing780 attached thereto. Adapter 770 includes a seal structure 178configured to connect to and seal with a 623 in mask 610. Module 768includes an opening 786 at an oral end thereof and an attenuator 784disposed within housing 782. A microphone element 800 is mounted facingopening 786 using a connector 776. Board 788 extends from a distal endto wall 773 of adapter 770. Board 788 can be used to avoid using wiringbetween mic elements and the connector 774 in wall 773. Connector 774can include a jack 772 for attaching a cable. Module 768 can have a wall(not shown) that originates at point 802 and extends transvers andaround element 802 to provide an aperture to seal element 800.

FIG. 27 describes yet another embodiment of a module 804 that includesan adapter 806 with a seal structure 812 and a housing extension 810 anda board 808. A removable cap provides access to attenuator 818 to makeit easily replaceable. Replacing attenuator 818 or a foam can beadvantageous to avoid harboring bacteria. This can be advantageous in acritical care setting where infections are particularly challenging forpatients to recover from. The cap can have a press fit, threads or anyother mechanism suitable for connecting the cap to the housing.

In some embodiments, the audio processing system, speaker, and batterypower can be built into the housing of the microphone adapter to avoidhaving cords or other elements attached to the patient. This embodimentis preferred where small speakers and limited power are suitable andwhere cords are particularly problematic. In other embodiments, themicrophone module connects to a speaker housing and/or amplifier housingincluding the amplification and signal processing components.

Additional details regarding the microphone system can be found inapplicant's co-pending provisional patent application Ser. No.62/612,303, filed Dec. 29, 2017, which is hereby incorporated herein byreference.

Ventilator GUI and Computer Implemented Methods for Controlling aVentilator Circuit During Oral Care and Tracking Oral Care Events

The present invention also relates to using ventilator system 24including ventilator unit 21 and embedded software systems in ventilatorunit 21 for providing ePAP and iPAP settings during oral care and/or formonitoring and tracking oral care. For instance, the ventilator unit 21may have an oral care setting that allows a clinician to select changedventilator settings or change the way in which the ventilator calculatesa setting such as breathing rate or the alarm. For instance, when oralcare suctioning is performed the pressure decreases, which can triggerthe ventilator to breath sooner. The oral care setting can compensatefor this effect by calculating a slower breathing rate while suctioningis being performed. In some embodiments, the ventilator alarm can be setat a higher leak rate to compensate for false alarms caused bysuctioning. In some embodiments, the oral care setting may have a timelimit. In another embodiment, the ventilator 21 may have a pressuresensor that detects the change in pressure and determines that thechange in pressure is a result of suctioning. For example, the pressuresensor data can be analyzed to identify a rate of change and/or a degreeof change that is characteristic of suctioning. For example, the rate ofchange will depend on the characteristics of opening the on/off switchin the suction handle and the amount of change will depend in large parton the diameter of the tubing used for an oral care appliance. Theventilator system can process the pressure senor data and detect changesthat are indicative of leak and compensate for the leak by driving thepressure generating unit and/or prevent an alarm from sounding. Thepressure sensor system may take a pressure measurement at least 1, 10,100, 500 times per second.

The ventilator software may also track oral care activities and/orprovide an indicator (e.g., reminder or a warning) for under-performingor over-performing oral care. In some embodiments, the indicator isbased on a hospital standard. The ventilator software may record time ofday, duration, and/or person that provides oral care for a particularpatient. The ventilator may automatically calculate a next time toperform oral care based on when a previous oral care was performed.

Methods for Using an Appliance while Maintaining Positive Pressure

Some embodiments of the invention relate to accessing the oral airway toperform procedures while maintaining positive pressure and performingoral care on a patient while maintaining sufficient pressure to provideclinically relevant breathing assistance and/or to maintain an openairway in the patient.

(i) Oral Care: The present invention also relates to methods forproviding oral care through a non-invasive positive pressure ventilationmask. The method includes (i) providing a positive pressure ventilationmask including where the mask includes, a mask body defining a cavityand having a peripheral seal configured to engage a wearer's face, anaccess valve providing external access to the cavity, and an inlet forreceiving pressurized air; (ii) pressurizing the mask to a pressure ofat least 200 Pa using a ventilator system (alternatively to a pressureof at least 1, 2, 5, 10, or 15 and/or less than 35, 30, 25, 20, 15 cmH₂O, and/or within a range of any of the foregoing pressures); and (iii)introducing an oral appliance into the cavity through the valve andmaintaining a pressure of at least 200 Pa (alternatively a pressure ofat least 2, 5, 10, or 15 cm H₂O and/or less than 35, 30, or 25 cm H₂O)while performing an oral or nasal care procedure.

In a preferred embodiment, a bi-level ventilator is used and the twodifferent pressures of the ventilator are different by at least 2, 4, 6,or 8 cm H₂O and/or less than 20, 15, or 10 cm H₂O.

The desired pressure is maintained by providing an appliance with anadapter that couples to the mask and maintains sufficient seal, or byproviding a valve in the mask that will seal around the appliance, orboth. For example, in some embodiments, the self-sealing and/orself-reverting valves described herein may be used for performing oralcare. Alternatively, or in addition, an appliance adapter as describedherein may be used with a port with a removable cap (see e.g., US Patentapplication publication 2010/0116276 to Bayasi). In either case, thevalve opening or port is preferably positioned over the oral cavityand/or has a relatively wide opening (e.g., the dimensions describedabove) to facilitating oral cleaning, which requires a large degree ofmanipulation to be performed properly.

In some embodiments, the oral care procedure includes applying acleaning fluid to a least a portion of the oral cavity and suctioningexcess cleaning fluid. The cleaning fluid may be water, mouth wash, ortoothpaste. The cleaning fluid may include a cleaning agent such as adebriding agent or an anti-microbial agent. For example, the cleaningfluid may include a solution having an anti-microbial (e.g.,cetylpyridinium chloride) in sufficient concentration to clean the oralcavity. For example, an antimicrobial may be added in a concentration ofat least 0.01, 0.05, or 0.1, or 0.5% and/or less than 1.0, 0.5, or 0.1%or within a range of the foregoing. For purposes of this invention,anesthetics suitable for numbing the throat (e.g., for performingintubation) are not a suitable “cleaning fluid” for performing the oralcare described herein.

When cleaning the oral cavity, the cleaning fluid is typically appliedto a majority of the surface of the mouth. In one embodiment, thecleaning fluid is applied to a least a portion of the gums and/or teeth.

The cleaning fluid may be provided in a container and a sponge on astick may be dipped into the container to absorb an amount of solution.The sponge and fluid is then inserted into the oral cavity through avalve in the mask and the sponge is used to scrub surfaces of the mouthof the patient, include the teeth, gums, tongue, and/or cheeks of apatient.

In some embodiments, the fluid may be delivered using an appliance thatalso includes suction. The surface can be scrubbed using the sponge andfluid and fluid that is squeezed onto the surface can be suctionedthrough a shaft of the appliance. In one embodiment, the appliance caninclude a selectable suction controller such that the user performingthe cleaning can select when to apply suction as the appliance is beingused. For example, the appliance can have an access port to the suctionchannel and the port can be opened and close by the user covering itwith his or her finger. In some embodiments, the appliance may includebristles for more rigorous cleaning of surfaces (e.g., teeth).

The appliance inserted through the valve may have a shaft that is rigidand straight, which allows it to be moved in an appliance adapter whilemaintaining a seal. However, in some embodiments, the shaft may have abend to allow easier access to the inside surface of the teeth.

The cleaning agent may be water or a mouth wash. A paste or othercarrier can also be used. However, where a sponge appliance is desired,the cleaning agent is preferably a fluid.

Alternatively, or additionally, the method may include applying awetting agent to the oral or nasal cavity. In some embodiments, thewetting agent may include a moisturizer (e.g., methylcellulose). In someembodiments, the wetting agent includes ice or ice water.

The method can include applying any anti-microbial or moisturizer knownto be suitable for application to the mouth or nose for purposes ofcleaning or wetting. Where a fluid is applied, the appliance used todeliver the fluid preferably includes suction. The use of an applianceto suction is important since the positive pressure is maintained duringthe treatment and it is important to avoid aspiration of excess fluids.

In some embodiments, the method is a treatment of the nose, includingtreating epistaxis, lubricating the nasal cavity, and/or treatingrhinorrhea. The appliance may also be used to treat itching or otherirritations or discomforts. For example, a sponge on a stick can be usedfor mild scratching of the skin.

The ventilation system used to provide positive air pressure can be anyknown in the art, including volume ventilators, pressure controlledventilators, bi-level positive airway pressure devices, continuouspositive airway pressure devices, fixed pressure device, automaticpositive airway pressure device, and expiratory positive airway pressuredevice.

The pressure during the oral or nasal care procedure is maintained atacceptable pressures for the patient such as a pressure of at least 300Pa, 400 Pa, 500 Pa, or 600 Pa and/or less than 5000, 4000, 3000 Paand/or within a range of the foregoing during use of an appliance in thevalve.

To perform proper oral care, the valve has an opening of a suitablediameter. In one embodiment, the valve has an opening with a diameter ofat least 5, 10, 15, 20, or 25 mm and/or less than 60, 50, 40, 30, or 20,and/or within a range of the foregoing sizes. During use of theappliance in the mask the valve may be opened to a width within theforegoing ranges.

The method may be performed with a valve incorporated into the body of amask. Alternatively, the valve may be incorporated into a conduit wherethe pressurized air flows into the inlet of the mask and the valve isconfigured to provide access to the cavity through the pressurized airinlet.

Unlike cleaning or wetting methods described in the prior art, themethods of the present invention can be carried out without removing themask and without exceeding the maximum leak rate for the ventilator.This approach provides substantial benefits identified and recognized bythe inventors. For example, by maintaining a suitable seal during use,the oral care adapter can be used on patients who are too ill to havethe mask removed for oral care. In addition, oral care may be performedby the patient themselves or a nurse, rather than a respiratorytherapist (Although the RT or doctor can also perform the oral care). Byfacilitating a system that can be used by patients and nurses, the careproviders can have sufficient resources to perform oral care on aregular basis, without substantially increasing the cost of care.

Another embodiment of the invention relates to performing anesophagogastroduodenoscopy (EGD) procedure under pressure. The methodThe method includes (i) providing a positive pressure ventilation maskincluding where the mask includes, a mask body defining a cavity andhaving a peripheral seal configured to engage a wearer's face, an accessvalve providing external access to the cavity, and an inlet forreceiving pressurized air; (ii) pressurizing the mask to a pressure ofat least 200 Pa using a ventilator system (alternatively to a pressureof at least 1, 2, 5, 10, or 15 and/or less than 35, 30, 25, 20, 15 cmH₂O, and/or within a range of any of the foregoing pressures); and (iii)introducing an endoscope into the cavity through the valve andmaintaining a pressure of at least 200 Pa (alternatively a pressure ofat least 2, 5, 10, or 15 cm H₂O and/or less than 35, 30, or 25 cm H₂O)while performing an EGD procedure. The endoscope may have suction and aworking channel and/or a plurality of working channels and a diameter ofat least 8 mm. The endoscope may include an appliance adapter configuredto engage a port of the mask and seal the endoscope while allowing theendoscope to be advanced and/or manipulated in the patient's airwaythrough the appliance adapter and the mask while maintaining the desirepressure.

The present invention also relates to methods performed using a biteblock adapter. The method includes (i) providing a positive pressureventilation mask including where the mask includes, a mask body defininga cavity and having a peripheral seal configured to engage a wearer'sface, an access valve providing external access to the cavity, and aninlet for receiving pressurized air; (ii) pressurizing the mask to apressure of at least 200 Pa using a ventilator system (alternatively toa pressure of at least 1, 2, 5, 10, or 15 and/or less than 35, 30, 25,20, 15 cm H₂O, and/or within a range of any of the foregoing pressures);and (iii) introducing an endoscope into the cavity through the valve andmaintaining a pressure of at least 200 Pa (alternatively a pressure ofat least 2, 5, 10, or 15 cm H₂O and/or less than 35, 30, or 25 cm H₂O)while performing an EGD procedure. The endoscope may have suction and aworking channel and/or a plurality of working channels and a diameter ofat least 8 mm. The endoscope may include an appliance adapter configuredto engage a port of the mask and seal the endoscope while allowing theendoscope to be advanced and/or manipulated in the patient's airwaythrough the appliance adapter and the mask while maintaining the desirepressure.

The present invention also includes methods for using any of the otherappliance modules or adapters as described herein. Applicant'sco-pending PCT Application No. PCT/US2016/039117 is hereby incorporatedherein by reference in its entirety. Any of the forgoing methods may becarried out using an appliance adapter to deliver an appliance throughthe valve.

EXAMPLES

The following examples provide specific configurations of systems,modules, and methods that can be carried out according to embodiments ofthe inventions described herein.

Example 1 (Appliance Module)

A positive pressure ventilation (PPV) appliance module, comprising: aPPV appliance adapter having a first seal surface and a second sealsurface, the first seal surface configured to form a first PPV seal withan access port of a PPV mask when attached thereto, the second sealsurface defining an appliance aperture that forms a second PPV seal withan appliance, the appliance adapter having an inside portion on a firstside of the first and second seals and an outside portion on a secondside opposite the first side, wherein the inside portion is exposed tothe pressure of the ventilator and the outside portion is exposed to apressure external to the PPV mask when the adapter is attached thereto;the appliance including an elongate member having a distal end and aproximal end, wherein the distal end includes a working head, theworking head having a larger diameter than the appliance aperture, whichprevents the working head from being passed through the applianceaperture, wherein the working head is positioned on the first side ofthe adapter and the proximal end is positioned on the second side of theadapter.

Example 2

The module of any of the foregoing examples, wherein (i) the applianceincludes a connector on the distal end of the elongate member that islarger than the appliance aperture, which prevents the connector frombeing passed through the appliance aperture (ii) the elongate member iscomprises a tube, (iii) the appliance includes a suction port and asuction tubing connector, (iii) the connector connects to a suctionhandle, the suction handle having a switch for turning suction on andoff and a suction tubing connector for attaching suction.

Example 3

The module of any of the foregoing examples, wherein (i) the applianceaperture has a circular cross section, (ii) the elongate member has acircular cross section, (iii) the tolerance between the elongate memberand the appliance aperture is less than 0.05, 0.025, 0.015, 0.0075, or0.0035, and/or greater than 0.0, 0.001, 0.0015, 0.003, 0.006, 0.012,inches and/or within a range of the foregoing endpoints (iv) theelongate member is rigid (v) the elongate member has a slidable sealingsurface; (vi) the sliding seal surface has a length of at least 1, 2, 3,4, or 5 inches and less than 15, 12, 10, or 8 inches (vii) the appliancehas a fully retracted and fully extended position and the slidablesealing surface maintains the PPV seal at intermediate positions betweenfully extended and fully retracted positions (viii) at the intermediatepositions the sealing surface and the aperture have a maximum gap ofless than 0.05, 0.025, 0.015, 0.0075, or 0.0035, or greater than 0.0,0.001, 0.0015, 0.003, 0.006, 0.012, inches and/or within a range of theforegoing endpoints; (ix) the elongate member with the slidable sealingsurface is an extruded tube or an injection molded tube, (x) the tubingis injected molded and has a sloped inner diameter within the region ofthe sealing surface; (xi) working head has a maximum diameter less than2, 1.5, 1.2, 0.8, or 0.6 and/or greater than 0.2, 0.3, 0.5, 0.7, 1.0 orwithin a range of the foregoing; (xii) the working head has a minimumdiameter less than 1.5, 1.2, 0.8, 0.6, or 0.4 and/or greater than 0.1,0.2, 0.3, 0.5, or 0.7, or within a range of the foregoing.

Example 4

The appliance module of any of the foregoing examples wherein theappliance adapter includes a receptacle that the working head can beretracted into during attachment of the adapter to an access port.

Example 5

The appliance module of any of the foregoing examples, wherein theappliance is or includes (i) a suction appliance, (ii) a capnometrysampling line, (iii) a microphone, (iv) a yankauer, (v) a suction swab,or (vi) a suction brush. The appliance may also be single use ordisposable (i.e., not manufactured for cleaning between patients).

Example 6

The appliance module of any of the foregoing examples, furthercomprising a lock feature configured to lock an adapter against axialmovement of the appliance in the aperture until the lock is released.

Adapter Examples Example 7

An appliance module as in any of the foregoing examples, wherein theadapter (i) seals with a ring connected to the PPV mask (ii) the ringsecures the valve to the shell or elbow of the mask, (iii) the ringincludes a lock feature for locking the adapter to the ring, (iv) thelock feature is a bayonet lock, (v) has a rib that mates with the ring,(vi) wherein the rib is chamfered, (vii) wherein the rib is less than0.1 or 0.05 inch (viii) has the aperture formed in a housing member,(ix) wherein the housing member is a septum (x) housing member isinjection molded with a housing wall of the adapter (xi) housing memberforms a proximal end to a receptacle formed in the inside portion of theadapter; (xii) the housing member has a minimum thickness less than 0.5,0.02, or 0.01 inch, (xiii) the length of the adapter from the sealstructure to an oral end is at least 0.3, 0.6, 1.2, 2.4, or 5 inchesand/or less than 8, 6, 4, 2, 1.5, 1, 0.6, or 0.3 inch and/or within arange of any of the foregoing endpoints, (xiv) the PPV seal is formedbetween surfaces of the adapter and access port having a gap less than0.02, 0.015, 0.01, 0.006, or 0.003 and at or greater than 0.0, 0.001,0.002, 0.003, 0.005, 0.006, 0.01 inch or within a range of the foregoingendpoints (xv) the inside portion has a maximum or minimum outerdiameter less than 3, 2, 1.5, 1.2, or 0.6 inch and/or greater than 0.3,0.6, 0.8, 1.0, 1.5 inch and/or within a range of the foregoingendpoints.

Suction Swab Examples: Example 8

The appliance module of any of the foregoing examples, wherein theworking head (i) comprises a swab, (ii) the swab comprises a spongematerial, (iii) the swab is adhered to the tubing (iv) the tubing is anextruded stick, (v) the swab is configured to engage the adapter when auser pulls on the tubing or a connector attached thereto to pull theadapter out of an access port by the tubing.

Suction Brush Examples: Example 9

The module as in any of the foregoing examples wherein (i) the suctionappliance includes a suction brush, (ii) the working head of the suctionbrush is a brush head with a plurality of bristles extending therefrom,(iii), at least one, or

preferably at least two suction inlets are formed in the brush head,(iv) the bristles are formed from bundles of fibers placed in a body ofthe brush head (e.g., U.S. Pat. Nos. 3,256,545 and 4,167,794), or areinjected molded elements extending molded with the brush head (v) thebrush head includes foam positioned on the head opposite the bristles,(v) a suction inlet is positioned through the foam.

Example 10

The module as in any of the foregoing examples, wherein (i) the suctionbrush head has a tubing connector (ii) the elongate tube is fixedlyattached in the tubing connector, (iii) the tubing connector comprisinga cylinder, (iv) the tubing connector has a depth of at least 0.05, 0.1,0.15, or 0.2 and/or less than 0.5, 0.3, 0.25, or 0.2 inch or within arange of any of the foregoing endpoints.

Example 11

The appliance module of any of the foregoing examples, wherein theworking head includes a suction brush; the brush adapter includes areceptacle configured to house the brush and an aperture centrallylocated at a proximal end of the receptacle; the suction brush includesa suction head with an elongate tubing connected to the head; theelongate tubing is centrally located on a proximal end of the head(i.e., the end closest to the aperture of the adapter) such that theadapter aperture and the suction brush tubing align axially. In someembodiments, the longitudinal axis of the tubing connector is off centerfrom the midpoint of the brush head by less than 30%, 20%, 10%, or 5% inwidth and/or height.

Yankauer Examples: Example 12

The module of any of the forgoing examples, wherein the working head (i)includes a plurality of suction inlets at or near the distal endthereof, (ii) the plurality of inlets are in fluid communication witheach other, (iii) the distal end includes a soft tip with a softermaterial than the elongate tubing, (iv) the distal end has a pluralityof ribs that capture the working head in a retracted position (v) theworking head has a stop feature inhibits movement through the aperture,(vi) the adapter includes a cover, (vii) the cover includes a pluralityof ribs that capture the working head of the appliance in theretracted/covered position or (viii) combinations thereof.

Oral Care Kit Examples: Example 13

An oral care kit comprising (i) a plurality of appliance modules of anyof the foregoing examples, (ii) a plurality of the same type and/ordifferent types of suction appliance modules, (iii) one of or aplurality of suction swab modules, (iv) one of or a plurality of suctionbrush modules, (v) one of or a plurality of swab applicators, (vi) oneof or a plurality of oral rinse solutions, (vii) one of or a pluralityof antiplaque solution (viii) one of or a plurality of solutions with anactive agent selected from cetylpyridinium chloride, hydrogen peroxide,or chlorhexidine, or a (ix) a suction handle, (x) individual treatmentpackages for performing a plurality of cleanings within a period of time(e.g., daily period), (xi) or combinations of these. The kit may alsoinclude a suction handle and/or have a connector with a suction port(e.g., thumb activated suction port).

Example 14

The oral care kit as in any of the foregoing examples comprising aplurality of individual packages, wherein at least a portion of theindividual packages include an oral appliance and an oral rinsesolution, the oral rinse solution packaged in a compartment of theindividual package, wherein (i) the individual packaging has tray withfirst and second compartments, the first compartment housing theappliance and the second compartment housing the oral rinse (ii) a peelmember covers the first and second compartments and peeling the coverexposes the appliance and at least a portion of the second compartment,thereby providing access to the oral rinse (iii) the first and secondcompartments have a perimeter seal that is stronger than a divider sealbetween the first and second compartments, (iv) a third compartment ispositioned between the first and second components (v) the oral rinse ispackaged in a sachet with a frangible seal (vi) the oral rinse ispackaged in a cup with a peal cover.

Adapter Examples: Example 15

An appliance module as in any of the foregoing examples, wherein theadapter (i) seals with a ring connected to the PPV mask (ii) the ringsecures the valve to the shell or elbow of the mask, (iii) the ringincludes a lock feature for locking the adapter to the ring, (iv) thelock feature is a bayonet lock, (v) has a rib that mates with the ring,(vi) wherein the rib is chamfered, (vii) wherein the rib is less than0.1 or 0.05 inch (viii) has the aperture formed in a membrane, whereinthe membrane is (i) injection molded, (ii) an injection molded structureof an injection molded adapter (iii) has a thickness less than 0.5,0.02, 0.01 inch.

Ventilator Examples: Example 16

A positive pressure ventilation system, comprising a ventilator controlmodule including one or more processes and computer executableinstruction that when executed on the one or more processors cause themodule to: (i) receive detected pressure input from a positive pressureventilation circuit, the circuit including a PPV mask; (ii) analyze thepressure input for a suction pressure signal indicative of changes inpressure caused by operation of a suction appliance in the PPV mask; and(iii) generate an output signal for driving a pressure generating systemusing at least in part the detected suction pressure signal.

Example 17

The ventilation system as in any of the foregoing examples wherein (i)the control module filters out at least a portion of the suctionpressure signal, (ii) wherein the suction pressure is detected from apressure signature that has changes in the rise, fall, rate of change,and/or duration in change of pressure that is different than a breathingpressure signature for rise, fall, and/or duration in change ofpressure, or (iii) combinations thereof.

Example 18

A positive pressure ventilation system, comprising a ventilator controlmodule including one or more processes and computer executableinstruction that when executed on the one or more processors cause themodule to: (i) receive detected pressure input from a positive pressureventilation circuit, the circuit including a PPV mask; (ii) display to auser a selectable oral care setting and receiving input from the userindicating selection of the oral care setting; (iii) upon receivinginput of the oral care setting being selected, adjusting a parameter ofthe ventilator.

Example 19

The system as in any of the foregoing, wherein (i) the adjustedparameter is an alarm setting, an iPAP setting, and/or a ePAP setting,wherein (ii) the alarm setting is set to increase a leak rate at whichan alarm is triggered, (iii) the alarm has a duration parameter thatlimits the change in the parameter to a particular amount of time, (iv)the duration parameter is less than 20, 15, 10, or 5 minutes and/orgreater than 1, 3, 5, or 10 minutes or within a range thereof, (v) iPAPis reduced, (vi) a pressure at which iPAP is triggered is reduced,(vii), the pressure at which ePAP is trigger is reduced, (vii) the rateof change in pressure needed to trigger ePAP or iPAP is increased, or(ix) combinations of the foregoing.

Example 20

The system as in any of the foregoing, wherein the suction applianceand/or the PPV mask are as in any of the forgoing examples.

Example 21

A PPV system comprising: a PPV mask with an access port; an appliancemodule, an oral care appliance module, a suction appliance module, acapnometry module, endoscopy module, or a nebulizer module as in any ofthe examples herein, wherein the module forms the first seal with theaccess port of the PPV mask, (i) wherein the module includes an adapterthat forms the first seal with the access port.

Example 22

The PPV system as in any of the foregoing examples, wherein (i) theaccess port is provided by an elbow connector of the mask, (ii) theaccess port is flexibly connected to a shell of the mask, (iii) whereinthe flexible connection is provided by mask a flexible shell region,(iv) wherein the flexible connection is provided by a flexible connectorbetween the access port and the shell, (v) or combinations of these.

Example 23

A method for performing oral care, suctioning, oral cleaning, orbrushing, comprising, providing a PPV system of any of the examplesherein, connecting the adapter to the access port, introducing theworking head of the appliance into the oral cavity, performing an oralprocedure using the working head, removing the adapter from the accessport. The method further comprising, one or more of suctioning, dippingthe working head in a solution, and/or scrubbing. The method furthercomprising, withdrawing the working head into the adapter and/or pullingthe adapter out of the access port by withdrawing the tubing from theadapter until the working head engages the adapter and forces theadapter from the access port.

Capnometry Examples. Example 24

A positive pressure ventilation (PPV) capnometry module, comprising: anelongate support housing sized and configured to be placed through anaccess port of a PPV mask, the support housing extending from an oralend to an external end opposite the oral end, the support housing sizedand configured to be placed through an access port of an PPV mask andform a first PPV seal therewith, wherein with the support housinginserted and sealed, the oral end is positioned in the oral end of apatient wearing the mask and the external end is external to the mask; acapnometry sampling line positioned within the support housing andhaving a sampling inlet positioned at or near the oral end of thesupport housing, the sampling inlet in fluid communication with anexterior of the support housing for sampling oral gasses, the samplingline passing through an aperture in the support housing to the outsideportion of the adapter and forming a second PPV seal with the elongatesupport housing or an adapter attached thereto, the sampling line havinga line connector distal to the external end and configured to attach thesampling line to a capnometry system suitable for measuring end tidalCO₂ of a sampled gas.

Example 25

The capnometry module as in example 1, wherein the capnometry module issized and configured to be inserted through (i) a slit valve positionedin an access port of the PPV mask, (ii) a valve that seals fromventilator pressure, (iii) or combinations of these.

Example 26

The capnometry module as in any of the foregoing examples, furthercomprising a PPV adapter having a first seal surface configured to formthe first PPV seal with the access port of the PPV mask when attachedthereto, the PPV adapter having an inside portion on a first side of thefirst seal surface and an outside portion on a second side opposite thefirst side, wherein the inside portion is exposed to the pressure of theventilator and the outside portion is exposed to a pressure external tothe PPV mask when the adapter is attached thereto.

Example 27

The capnometry module as in any of the foregoing examples, wherein thefirst seal surface is positioned a body of the adapter and the elongatehousing is an extension of the adapter body or fixedly attached thereto,wherein the sampling line forms the second seal with the adapter body.

Example 28

The capnometry module as in any of the foregoing examples, wherein thefirst seal surface is provided by a body of the adapter and the supporthousing is slidably attached to the adapter body such that a depth ofthe oral end of the support housing is adjustable within the PPV maskrelative to the adapter.

Example 29

The capnometry module as in any of the foregoing examples, wherein thesupport housing has a second end opposite the oral end, the supporthousing extending through an outside portion of the adapter to thesecond end and having a proximal connector that forms the second sealwith the sampling line, the outside connector providing a grip surfacesuitable for a user to slidably adjust the depth of the support housingrelative to the adapter body.

Example 30

The capnometry module as in any of the foregoing examples, wherein thesupport housing can be slidably adjusted to a covered position in whichthe sampling inlet of the oral end is positioned within a cover portionof the adapter body for storage and an extended position in which thesampling inlet of the oral end is extended for use in samplingexhalation gases in the oral cavity.

Example 31

The capnometry module as in any of the foregoing examples, wherein afirst end of a sheath is connected to the adapter body and a second endof the sheath is connected to the second end of the support housing, thesheath being flexible such that it compresses when the support housingis moved from the covered position to the extended position.

Example 32

The capnometry module as in any of the foregoing examples furthercomprising a casing attached the support housing at or near the oralend, wherein the sampling inlet is formed in the casing wherein (i) thecapnometry module as in any of the foregoing examples, wherein thecasing is made from a softer material than the support housing (e.g., arubber material); (ii) the support housing comprises tubing and thecasing covers the tubing wall at the oral end; (iii) the housing tubingincludes one or a plurality of apertures in the tubing wall that arepositioned to allow exhalation gases to pass into and out of the housingtube when the mouth of the patient is sealed around the tubing; (iv) thesampling line has an internal diameter greater than 0.5, 0.8, or 1 mmand/or less than 5, 4, 3, 2, mm or within a range of the foregoingendpoints.

Example 33

A PPV system comprising: a PPV mask with an access port; and thecapnometry module of any of the forgoing examples attached to the accessport.

Example 34

The PPV system as in any of the forgoing examples, wherein (i) the PPVmask includes a valve in the access port (ii) the valve is a slit valveand the support housing seals with the slit valve, (iii) the valve is aself-sealing valve or a valve that seals under PPV, (iv) the moduleincludes a capnometry adapter that seals with the access port (iii) theaccess port is positioned in a shell of the mask or an elbow connectorof the mask.

Nebulizer Examples: Example 35

A positive pressure ventilation (PPV) nebulizer module, comprising: anebulizer adapter having a first seal surface configured to form a PPVseal with an access port of a PPV mask when attached thereto, thenebulizer adapter having an inside portion on a first side of the firstseal and an outside portion on a second side opposite the first side,wherein the inside portion is exposed to the pressure of the ventilatorand the outside portion is exposed to a pressure external to the PPVmask when the adapter is attached thereto; a fluid reservoir formed inthe module, the fluid reservoir having an inlet port that opens andcloses for filling the reservoir with a nebulization fluid; a tubularstructure defined by or connected to the inside portion of the adapter,at least a portion of the tubular structure positioned within the PPVmask when the adapter is attached thereto; the tubular structure havingan oral end (either forming an opening or having the aerosol elementgenerator positioned therein); a aerosol generator positioned in thetubular structure (optionally at an end of the tubular structureopposite the oral end), a first side of the vibrating element in fluidcommunication with the tubular structure (or positioned at the oral end)and a second opposite side of the vibrating element in fluidcommunication with the reservoir; a plurality of electrical leadsconnected to the vibrating element for receiving a signal to power thevibrating element.

Example 36

A nebulizer module as in any of the foregoing examples, wherein (i) theaerosol generator is positioned within the module such that thevibrating element is positioned within an elbow connector or a shell ofthe PPV mask when the adapter is attached thereto, (ii) the inlet portof the reservoir is positioned on the outside portion of the adapter;(iii) the inlet port is positioned on the inside portion of the adapter(iv) the reservoir has a sloped wall that ends in a recess at a base ofthe vibrating element; (v) a moisture sensor element within thereservoir (vi) the moisture sensor element positioned within the recessat the base of the vibrating element; (vii) the sealing surface of theadapter is configured to slidably connect with an opening of the accessport; (viii) the opening having a circular cross-section, (ix) theadapter when attached to the mask is configured to open a valve in theaccess port, (x) the access port has a cross section with a minimumwidth and/or height (i.e., x and y) of at least 0.2, 0.3, 0.4, 0.5, 0.6,0.8 inch and less than 2.0, 1.5, 1.25, or 1.0 inch and/or a range withinthe foregoing (xi) the opening has a cross section with a maximum widthand/or height less 3.0, 2.0, 1.5, 1.25, or 1.0 and/or greater than 0.4,0.6, 0.8, 1.0, 2.0, 3.0, (xiii) the adapter includes a lock feature thatlocks the adapter to the access port; (xiv) the lock feature is abayonet lock, (xv) the adapter has a rib that mates with the ring, (xvi)wherein the rib is chamfered, (xvii) wherein the rib is less than 0.1 or0.05 inch (xviii) the tubing structure is formed in a support housingthat slidably connects to a body of the adapter, where the adapter bodyincludes the seal (see capnometry adapter), (xix) the reservoir has avolume less than 50, 40, 30, or 25 ml and/or greater than 2, 4, 8, 12,or 20 ml and/or within a range of the foregoing, (xx) a wire connectorfor receiving nebulization control signal from a control module or (xxi)combinations of the foregoing.

Example 37

The nebulizer module as in any of the foregoing examples, wherein theadapter houses (i) a battery, (ii) a circuit board powered by thebattery, (iii) the circuit board is configured to drive the nebulizerelement, (iv) a nebulization on and/or off button, (v) LED indicator forbattery and/or on/off, (vi) the button has haptic feedback to indicateon/off of nebulization and/or on/off of auto-off; the circuitry isconfigured to turn the circuity off based on a lack of moisture asindicated by the moisture sensor, (vii) wherein the adapter extends amaximum of less than 3.0, 2.5, 2.0, 1.5, or 1.0 inches from the accessport when the adapter is attached thereto.

Example 38

A positive pressure ventilation (PPV) nebulizer system, comprising: aPPV mask comprising a shell and a cushion, the cushion having a membraneconfigured to seal with a face under positive pressure from aventilator, the shell having an access port with a valve that sealsunder pressure from the ventilator; a PPV nebulizer adapter thatremovably connects to the access port of the mask and opens the valvewhen connected thereto, the adapter including a tubular structure thatprovides a fluid pathway for nebulized gases through the valve whenattached to the access port; a nebulizer in fluid communication with thetubular structure of the adapter, the nebulizer including a fluidreservoir, a nebulizer module, and a conduit for delivering nebulizedgasses from the nebulizer module to the tubular structure of theadapter.

Example 39

The nebulizer system of any of the foregoing examples, wherein (i) thenebulizer module includes a sonication disc, (ii) the sonication discincludes a vibrating element, (iii) the sonication disc is powered by abattery, (iv) the nebulizer module is portable and integrated into theadapter, (v) the nebulizer module connects to a source of air that isforced through fluids from the reservoir to cause nebulization, (v) andcombinations of these.

Example 40

The nebulizer system of any of the foregoing examples, wherein (i) theaccess port is formed in an elbow connector of the mask, (ii) the valveis a cross-slit valve and/or a duck bill valve, and/or (iii)combinations of these.

Example 41

A nebulizer adapter as in any of the foregoing examples.

Example 42

A method for performing nebulization, comprising, providing anebulization system as in any of the foregoing examples, introducing anebulizable fluid into the fluid reservoir of the nebulizer module,nebulizing the fluid using the nebulizer apparatus, and delivering thenebulized fluid into the mask while providing pressure in the mask froma ventilator connected thereto.

Endoscopy Examples Example 43

A positive pressure ventilation (PPV) endoscopy system, comprising: aPPV mask comprising a shell and a cushion, the cushion having a membraneconfigured to seal with a face under positive pressure from aventilator, the shell having an access port with a valve that sealsunder pressure from the ventilator; a PPV endoscopy adapter thatremovably connects to the access port and opens the valve when connectedthereto, the adapter including a tubular structure that has a valvepositioned therein, the valve being configured to form a slidable sealwith an endoscope.

Example 44

The endoscopy system of any of the foregoing examples, wherein (i) theaccess port is formed in an elbow connector of the mask, (ii) the valveis a cross-slit valve and/or a duck bill valve, (iii) the valve is overmolded in an injection molded process with the adaptor, or (iv)combinations of these.

Example 45

The endoscopy system as in any of the foregoing examples, wherein theadapter further comprises a bite block; (i) wherein the bite blockextends through the adapter or forms an integral part of the adapter(ii) the bite block is sufficiently long to pass between the teeth of apatient when the adapter is positioned in the access port.

Example 46

An endoscopy adapter as in any of the foregoing examples.

A method for performing an endoscopy procedure, comprising, providing anendoscopy system as in any of the foregoing examples, introducing theendoscopy adapter in the PPV mask and introducing an endoscope in theendoscopy adapter under pressure from a ventilator connected to the PPVmask.

We claim:
 1. A positive pressure ventilation (PPV) elbow for accessingthe oral cavity of a patient wearing a PPV mask under pressure,comprising: a housing forming an elbow and defining an air-supplyconduit extending between an air supply inlet and an air supply outlet,the air supply conduit configured to deliver pressurized air from theinlet to the outlet; a mask connector configured to attach to a positivepressure ventilation mask; an access port formed through the housinginto the conduit, the access port providing access to the mouth of apatient wearing the mask with the elbow connected thereto; an accessvalve positioned in the port and configured to self-seal from ventilatorpressure.
 2. The elbow as in claim 1, wherein the access valve isself-sealing at a pressure in a range from 5-15 cm H₂O.
 3. The elbow asin claim 2, wherein the access valve is self-reverting.
 4. The elbow asin claim 3, wherein the access valve includes a valve rim and aplurality of leaflet, wherein the valve rim is connected to the housingof the elbow and the leaflets are positioned within the conduit thereof.5. The elbow as in claim 3, wherein the access valve includes one ormore slits that allow the valve to be opened, the valve configured toseal the one or more slits from ventilator pressure applied to thevalve.
 6. The elbow as in claim 5, wherein the access valve includes across slit.
 7. The elbow as in claim 5, wherein the access valve is aduckbill valve.
 8. The elbow as in claim 1, wherein the access valvecomprises one or more leaflets responsive to pressure for sealing thevalve.
 9. The elbow as in claim 8, wherein at least a portion of eachleaflet has a thickness less than 2 mm.
 10. The elbow as in claim 1,wherein the access valve opens to a diameter of at least 10 mm.
 11. Theelbow connector as in claim 1, further comprising an anti-asphyxiationvalve that opens to the ambient when the ventilator pressure is lost.12. The elbow connector as in claim 1, wherein the mask connector isremovably attaches to the mask.
 13. A positive pressure ventilation maskcomprising the elbow of claim
 1. 14. A positive pressure ventilationmask as in claim 13, wherein the mask includes a mask shell and whereinthe elbow swivels relative to the shell.
 15. A positive pressureventilation system comprising the positive pressure ventilation mask ofclaim 13, wherein the system is configured to pressurize the mask to apressure within 5-15 cm H₂O.
 16. A positive pressure ventilation (PPV)elbow for accessing the oral cavity of a patient wearing a PPV maskunder pressure, comprising: a housing forming an elbow and defining anair-supply conduit extending between an air supply inlet and an airsupply outlet, the air supply conduit configured to deliver pressurizedair from the inlet to the outlet; a mask connector configured toremovably attach to a positive pressure ventilation mask; an access portformed through the housing into the conduit, the access port providingaccess to the mouth of a patient wearing the mask with the elbowconnected thereto, the port providing direct access to the mouth of thepatient through the mask connector; an access valve positioned in theport and having an open diameter of at least 5 mm, the access valveincluding a plurality of leaflets configured to open in response to anobject placed therethrough and form a seal therebetween from ventilatorpressure when the object is removed, the leaflets configured toself-revert after being inverted.
 17. A positive pressure ventilationmask comprising the elbow of claim
 16. 18. A positive pressureventilation mask as in claim 17, wherein the mask includes a mask shelland wherein the elbow swivels relative to the shell.
 19. A positivepressure ventilation system comprising the positive pressure ventilationmask of claim 17, wherein the system is configured to pressurize themask to a pressure within 5-15 cm H₂O.
 20. A method for treating apatient for a respiratory condition, comprising, providing a ventilatorcircuit including a ventilator unit, tubing, and a PPV mask with theelbow of claim 1 attached thereto; placing the mask on the face of apatient and pressurizing the ventilator circuit to a pressure greaterthan 4 cm H₂O, wherein the pressure in the ventilator circuit causes aseal to form between the mask and the face of the patient and causes theaccess valve to seal more tightly as compared to no pressure in theventilator circuit; inserting an appliance through the access valve andinto the mouth of the patient and removing the appliance, wherein uponremoving the appliance from the access valve, the access valve sealsfrom the ventilator pressure.